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Harvard Journal of Law & Technology
Volume 25, Number 1 Fall 2011
MUCH ADO ABOUT DATA OWNERSHIP
Barbara J. Evans*
TABLE OF CONTENTS
I. INTRODUCTION ................................................................................ 70 II. WHY DATA OWNERSHIP WOULD NOT PROTECT PATIENTS’
PRIVACY .......................................................................................... 77 A. Nonconsensual Access to Patient Data Under a
Property Regime....................................................................... 77 B. Nonconsensual Data Access Under the Existing Federal
Regulations ............................................................................... 82 III. WHY DATA OWNERSHIP CANNOT RESOLVE DATA
ACCESS PROBLEMS ......................................................................... 86 A. Identifying the Valuable Data Resources ................................... 90 1. Records of a Patient’s Various Encounters with the
Healthcare System ............................................................. 90 2. The Patient’s Longitudinal Health Record (“LHR”) ............... 90 3. Longitudinal Population Health Data (“LPHD”) .................... 91 4. Unbiased LPHD ....................................................................... 91 B. The Problem of Linking Data Across Healthcare Data
Environments............................................................................ 93 C. Consent Bias and the Need for Nonconsensual Access to
Patients’ Health Data .............................................................. 95 D. The Role of Infrastructure and Demand-Side Factors ............... 98 E. Why Data Propertization Proposals Fail ................................. 106 IV. THE HITECH ACT’S STRATEGY FOR PROMOTING
INFRASTRUCTURE DEVELOPMENT ................................................ 108 A. The Regulated Price of Infrastructure Services ....................... 108 B. Why the HITECH Act’s Approach Offers Promise .................. 110 V. WHAT STILL NEEDS TO BE DONE ................................................. 113 * Professor; Co-director, Health Law & Policy Institute; Director, Center for Biotechnology & Law, University of Houston Law Center. Contact [email protected] J.D., Yale
Law School; Ph.D., Stanford University; Post-doctoral Fellow, The University of Texas
M.D. Anderson Cancer Center. This research was supported by the Greenwall Foundation
and the University of Houston Law Foundation. The author would like to thank Baruch A.
Brody, Robert A. Burt, Christine K. Cassel, Fred H. Cate, James W. Curran, Karla K.C.
Holloway, Bernard Lo, Deven McGraw, Deborah Peel, Richard Platt, and Kristen Rosati for
their insights and encouragement in this research.
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Harvard Journal of Law & Technology
[Vol. 25
A. Restoring the Proper Scope of the State’s Police Power
to Use Data to Promote Public Health .................................. 114 B. Developing a Workable Doctrine of Public Use of
Private Data ........................................................................... 119 1. How the Public Use Requirement Got Lost .......................... 120 2. Clarifying the Concept of Public Use of Data in
Research .......................................................................... 124 3. Developing a Workable Public Use Criterion ....................... 126 A. Focus Not on How Decisions Should Be Made, but
by Whom ................................................................... 126 B. Develop Rules of Thumb for Identifying Suspect,
“Non-Public” Uses of Data ..................................... 127 C. Reject Utilitarian Balancing in Favor of Natural
Rights Analysis ......................................................... 127 VI. CONCLUSION ............................................................................... 129 I. INTRODUCTION
The Health Insurance Portability and Accountability Act of 1996
(“HIPAA”)1 Privacy Rule,2 a major federal regulation affecting health
information privacy, is criticized both for hindering access to health
data3 and for allowing too much data access.4 Similar concerns5 sur1. Health Insurance Portability and Accountability Act of 1996, Pub. L. No. 104-191, 110
Stat. 1936 (codified as amended in scattered sections of 18, 26, 29 and 42 U.S.C.).
2. 45 C.F.R. pts. 160, 164 (2010).
3. COMM. ON HEALTH RESEARCH AND THE PRIVACY OF HEALTH INFO.: THE HIPAA
PRIVACY RULE, INST. OF MED., BEYOND THE HIPAA PRIVACY RULE: ENHANCING
PRIVACY, IMPROVING HEALTH THROUGH RESEARCH 66 (Sharyl J. Nass, Laura A. Levit &
Lawrence O. Gostin eds., 2009) [hereinafter IOM, PRIVACY REPORT], available at
http://www.nap.edu/catalog/12458.html; see also William Burman & Robert Daum, Infection Diseases Society of America, Grinding to a Halt: The Effects of the Increasing Regulatory Burden on Research and Quality Improvement Efforts, 49 CLINICAL INFECTIOUS
DISEASES 328, 328 (2009) (arguing that “the application of the Health Insurance Portability
and Accountability Act to research has overburdened institutional review boards (IRBs),
confused prospective research participants, and slowed research and increased its cost”);
Fred H. Cate, Protecting Privacy in Health Research: The Limits of Individual Choice, 98
CALIF. L. REV. 1765, 1797 (2010) (“Consent requirements [imposed by the HIPAA Privacy
Rule] not only impede health research, but may actually undermine privacy interests.”).
4. IOM, PRIVACY REPORT, supra note 3, at 66 (noting that the HIPAA Privacy Rule has
not eliminated the concerns of the public, which is “deeply concerned about the privacy and
security of personal health information,” and reporting that “[i]n some surveys, the majority
of respondents were not comfortable with their health information being provided for research except with notice and express consent”).
5. See HHS, Human Subjects Research Protections: Enhancing Protections for Research
Subjects and Reducing Burden, Delay, and Ambiguity for Investigators, 76 Fed. Reg.
44,512, 44,523 (July 26, 2011) (to be codified at 45 C.F.R. pts. 46, 160, 164 and 21 C.F.R.
pts. 50, 56) [hereinafter HHS, ANPRM] (noting in connection with a proposal to amend the
Common Rule that “[c]ritics of the existing rules have observed that the current requirements for informed consent for future research with pre-existing data and biospecimens are
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Much Ado About Data Ownership
71
round the Federal Policy for the Protection of Human Subjects,6 or
“Common Rule.”7 While designed mainly to protect people who serve
as subjects of experiments,8 the Common Rule also applies to informational research9 that merely uses people’s data or biospecimens.10
It thus plays an important role in regulating access to, and use of, people’s health data. These regulations evolved over a twenty-eight-year
period that began when the National Research Act of 197411 set up a
National Commission12 to develop the Common Rule. The period
ended in 2002 when the HIPAA Privacy Rule was promulgated in its
present form,13 which draws heavily on concepts from the Common
Rule.14
confusing and consume substantial amounts of researchers’ and [Institutional Review
Boards’] time and resources”); id. at 44,525 (“[O]ther fundamental protections for research
participants may be warranted beyond updating the requirements for independent review
and informed consent currently provided by the Common Rule.”).
6. See Federal Policy for the Protection of Human Subjects (“Common Rule”), U.S.
DEP’T OF HEALTH & HUMAN SERVS., http://www.hhs.gov/ohrp/humansubjects/
commonrule/index.html (last visited Dec. 21, 2011).
7. 45 C.F.R. §§ 46.101–46.124 (2010).
8. See U.S. DEP’T OF HEALTH, EDUC., & WELFARE, PROTECTION OF HUMAN SUBJECTS:
INSTITUTIONAL REVIEW BOARDS: REPORT AND RECOMMENDATIONS OF THE NATIONAL
COMMISSION FOR THE PROTECTION OF HUMAN SUBJECTS OF BIOMEDICAL AND
BEHAVIORAL RESEARCH, 43 Fed. Reg. 56,174 (Nov. 30, 1978) [hereinafter HEW, 1978
REPORT] (discussing the various types of research considered during development of the
Common Rule); see also infra Part V (discussing the evolution of the Common Rule).
9. “Informational research” is one of many terms that refer to studies that use data and
biospecimens. See, e.g., HEW, 1978 REPORT, supra note 8, at 56,181–82 (using the older
phrase “research using . . . records” to refer to informational research); BENGT D. FURBERG
& CURT D. FURBERG, EVALUATING CLINICAL RESEARCH: ALL THAT GLITTERS IS NOT
GOLD 29–37 (2d ed. 2007) (using the term “observational” to refer to methodologies that
study data); David Casarett, Jason Karlawish, Elizabeth Andrews & Arthur Caplan, Bioethical Issues in Pharmacoepidemiologic Research, in PHARMACOEPIDEMIOLOGY 587, 588
(Brian L. Strom ed., 4th ed. 2005) (preferring the term “epidemiologic research”); IOM,
PRIVACY REPORT, supra note 3, at 7 (distinguishing “information-based” research from
clinical research); Brian L. Strom, Study Designs Available for Pharmacoepidemiology
Studies, in PHARMACOEPIDEMIOLOGY, supra at 18, 21–26, (discussing the array of scientific
methodologies — including observational studies that use existing data — for studying how
people react to drugs).
10. 45 C.F.R. § 46.102(f) (2010) (defining “human subject” to include living individuals
about whom an investigator obtains identifiable private information); Guidance on Research
Involving Coded Private Information or Biological Specimens, U.S. DEP’T OF HEALTH &
HUMAN SERVS., http://www.hhs.gov/ohrp/policy/cdebiol.html (last visited Dec. 21, 2011)
[hereinafter OHRP Guidance] (interpreting how the Common Rule applies to research with
data and biospecimens and describing circumstances in which such research will be subject
to the Common Rule's informed consent requirements).
11. National Research Act of 1974 (National Research Service Award Act of 1974), Pub.
L. No. 93-348, 88 Stat. 342 (codified as amended in scattered sections of 42 U.S.C.).
12. See HEW, 1978 REPORT, supra note 8, at 56,174 (discussing the National Commission and reporting its findings).
13. See Standards for Privacy of Individually Identifiable Health Information, 67 Fed.
Reg. 53,182 (Aug. 14, 2002) (codified as amended at 45 C.F.R. pts. 160, 164) (implementing the currently effective version of the HIPAA Privacy Rule). But see Modifications to the
HIPAA Privacy, Security, and Enforcement Rules Under the Health Information Technolo-
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Harvard Journal of Law & Technology
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Regulatory approaches that have worked fairly well in clinical research15 “are not easily exported and applied to the very different
challenges of [informational] research.”16 As the Department of
Health and Human Services (“HHS”) was developing the HIPAA Privacy Rule in 2000, multiple public commenters, including several
members of Congress, voiced this same concern.17 Research with data
and tissues has grown in importance,18 making these problems more
apparent and fueling calls for reform. In 2009, the Institute of Medicine (“IOM”) called for changes to the HIPAA Privacy Rule.19 The
IOM recommended replacing the Privacy Rule with an unspecified
“new approach” for regulating privacy and access to data for use in
health research.20 HHS recently published an advance notice of proposed rulemaking (“ANPRM”),21 which called for changes to the
Common Rule but offered few specifics, instead posing seventy-four
broad questions for public comment.22
Rather than reforming the regulations, other proposals seek legislation to clarify data ownership.23 Ownership of the data held in adgy for Economic and Clinical Health Act, 75 Fed. Reg. 40,868 (July 14, 2010) (to be codified at 45 C.F.R. pts. 160, 164) (proposing changes to the HIPAA Privacy Rule that have
not been finalized as of this writing).
14. See discussion infra Part II.B (discussing similarities between the Privacy Rule and
the Common Rule).
15. See LAWRENCE M. FRIEDMAN, CURT D. FURBERG & DAVID L. DEMETS,
FUNDAMENTALS OF CLINICAL TRIALS 2–5 (3d ed. 1998) (discussing clinical research, exemplified by a randomized, controlled clinical trial that monitors outcomes prospectively in
two groups of people who either are or are not subjected to a particular treatment).
16. Casarett et al., supra note 9, at 587.
17. See Standards for Privacy of Individually Identifiable Health Information, 65 Fed.
Reg. 82,462, 82,690–91 (Dec. 28, 2000) (codified as amended at 45 C.F.R. pts. 160, 164)
(responding to comments that it was inappropriate for the HIPAA waiver provision to be
“modeled on the existing system of human subject protections” and that “the Common
Rule’s requirements may be suited for interventional research involving human subjects, but
is ill suited to the archival and health services research typically performed using medical
records without authorization”).
18. See, e.g., Fred D. Brenneman et al., Outcomes Research in Surgery, 23 WORLD J.
SURGERY 1220 (1999) (discussing the growth of informational research after 1980); Outcomes Research Fact Sheet (2000), AGENCY FOR HEALTHCARE RESEARCH AND QUALITY,
http://www.ahrq.gov/clinic/outfact.htm (last visited Dec. 21, 2011) [hereinafter AHRQ,
Fact Sheet] (same); see also Barbara J. Evans & Eric M. Meslin, Encouraging Translational
Research Through Harmonization of FDA and Common Rule Informed Consent Requirements for Research with Banked Specimens, 27 J. LEGAL MED. 119, 122 (2006) (discussing
the growing importance of research with biospecimens); Rina Hakimian & David Korn,
Ownership and Use of Tissue Specimens for Research, 292 JAMA 2500, 2500 (2004)
(same).
19. IOM, PRIVACY REPORT, supra note 3, at 28–29 (summarizing the IOM’s recommendations).
20. Id. at 28.
21. See HHS, ANPRM, supra note 5, at 44,512.
22. Id. at 44,517–29.
23. See, e.g., Mark A. Hall, Property, Privacy, and the Pursuit of Interconnected Electronic Medical Records, 95 IOWA L. REV. 631, 651 (2010) (“[I]f patients were given owner-
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Much Ado About Data Ownership
73
ministrative24 and clinical databases is a matter of state law and, in
most states, data ownership is not clearly defined.25 Patient data ownership is touted by some observers as a way to enhance patient privacy26 and by others as a way to make data more widely available for
ship of their complete medical treatment and health histories, they could license to compilers their rights to that information in a propertized form that could be more fully developed
and commercialized.”); Marc A. Rodwin, Patient Data: Property, Privacy & the Public
Interest, 36 AM. J.L. & MED. 586, 589 (2010) (arguing for public ownership of de-identified
patient data).
24. See Leslie L. Roos et al., Inst. of Med., Strengths and Weaknesses of Health Insurance Data Systems for Assessing Outcomes, in MODERN METHODS OF CLINICAL
INVESTIGATION 47, 47, 52 (Annetine C. Gelijns ed., 1990), available at
http://www.nap.edu/openbook.php?record_id=1550 [hereinafter IOM, MODERN METHODS]
(discussing health research that uses administrative data, such as claims data held by Medicare, Medicaid, and private health insurers).
25. See Barbara J. Evans, Congress’ New Infrastructural Model of Medical Privacy, 84
NOTRE DAME L. REV. 585, 596–97 (2009) (discussing the current status of ownership of
health data and human tissue specimens); David L. Silverman, Data Security Breaches: The
State of Notification Laws, 19 INTELL. PROP. & TECH. L.J., July 2007, at 5, 8 (discussing the
“precarious” nature of ownership of database content under current law). But see Susan E.
Gindin, Lost and Found in Cyberspace: Informational Privacy in the Age of the Internet, 34
SAN DIEGO L. REV. 1153, 1195 n.231 (1997) (noting several cases where courts have recognized patients’ ownership of medical records); Seth Axelrad, State Statutes Declaring
Genetic Information to be Personal Property, AM. SOC’Y OF L., MED. & ETHICS,
http://www.aslme.org/dna_04/reports/axelrad4.pdf (last visited Dec. 21, 2011) (listing four
states — Alaska, Colorado, Florida, and Georgia — that recognize individual property
rights in one category of health data, genetic information).
26. See, e.g., Deborah C. Peel, Written Testimony Before the HIT Policy Committee,
ELECTRONIC PRIVACY INFO. CENTER (Sept. 18, 2009), http://epic.org/privacy/medical/Peel_
PPR%20Written%20testimony%20HIT%20Policy%20Committee.pdf
(indicating
that
“twenty focus groups held across the country in order to understand consumers’ awareness,
beliefs, and fears concerning [health information technology]” discovered that “[a] majority
want to ‘own’ their health data”); Principles: More Patient Privacy Principles, PATIENT
PRIVACY RIGHTS, http://patientprivacyrights.org/principles (last visited Dec. 21, 2011)
(listing a set of eleven “Patient Privacy Principles [that] should be included in all Health
[information technology] legislation” and listing as the first such principle, “[r]ecognize that
patients own their health data”). Patient data ownership advocates often ground their position in the claim that privacy is a state in which patients exercise full control over their own
health information. See Peel, supra (framing privacy as “control of personal information”
and “consumer control over [personal health information]”). Patients want assured access to
the data about themselves that are maintained or stored by others. See Richard H. Thaler,
Show Us the Data. (It’s Ours, After All.), N.Y. TIMES, Apr. 23, 2011, at BU4 (discussing “a
host of privacy issues” raised by collection and dissemination of personal data and calling
for persons whose data is stored to have access to it); Elizabeth Cohen, Patients Demand:
“Give Us Our Damned Data”, CNN (Jan. 14, 2010), http://articles.cnn.com/2010-0114/health/medical.records_1_hospital-bed-patients-demand-medical-records; Leslie A.
Saxon, Owning Your Health Information: An Inalienable Right, THE HUFFINGTON POST
(Oct. 7, 2009), http://www.huffingtonpost.com/leslie-a-saxon-md/owning-your-healthinform_b_312852.html (discussing data ownership as a way to enhance patients’ access to
data). Another desired aspect of privacy is for patients to be able to control others’ access to
and use of the patients’ data). See A Declaration of Health Data Rights,
HEALTHDATARIGHTS.ORG, http://www.healthdatarights.org (last visited Dec. 21, 2011)
(advocating a “self-evident and inalienable” entitlement not only to “[h]ave the right to our
own health data” but also to “have the right to share our health data with others as we see
fit”).
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research.27 Still others call for public (governmental) ownership to
enhance researchers’ access to data.28 While differing in details, data
propertization proposals seem to agree that property rights in data are
important and that clarifying them should be high on the legislative
agenda.29 Ominously, this view is starting to infect policymakers,30
raising a real risk that what began as an abstract scholarly debate may
end in ill-advised legislation.
The urge to propertize health data needs to be weighed skeptically
and with a clear understanding of how property rights actually work.
If pursued, data ownership may disappoint many of its proponents
because of a surprising truth: the framework of patient entitlements
and protections afforded by the HIPAA Privacy Rule and the Common Rule is strikingly similar to what patients would enjoy if they
owned their data.31 Part II challenges the claim that private data ownership would improve privacy protection. It finds that both regimes —
patient ownership of data, on the one hand, and the federal regulatory
protections, on the other — provide pliability-rule protection32 that
strikes a balance between patient control and the public’s need for
data access. Both regimes allow some unconsented uses of patients’
27. See Hall, supra note 23, at 651; see also Mark A. Hall & Kevin A. Schulman, Ownership of Medical Information, 301 JAMA 1282, 1283–84 (2009) (discussing advantages of
patient-controlled longitudinal health records and suggesting that one way to foster the
development of such records would be to “give patients the rights to sell access to their
records, rights that are superior to the property rights held by [entities that currently hold
patients’ data]”).
28. See Marc A. Rodwin, The Case for Public Ownership of Patient Data, 302 JAMA 86,
87–88 (2009) (arguing for governmental ownership of de-identified patient data).
29. See, e.g., Hall, supra note 23, at 637 (“The law’s uncertainty over ownership and control of medical information is widely regarded as a major barrier to effective networking of
[electronic medical records], and policy analysts consider the legal status of medical information to be a critical question at or near the top of issues needing resolution.”); id. at 631
(“How this issue is resolved can determine how or whether massive anticipated developments in electronic health records will take shape.”); Rodwin, supra note 23, at 586 (“How
the law defines ownership of patient data will shape whether its benefits can be developed
and also affects patient confidentiality.”).
30. See, e.g., H. COMM. ON PUB. HEALTH, INTERIM REP. TO THE 82ND TEX. LEG., H. 82C410, 1st Sess., at 17, 20–21 (2010) (stating as its first recommendation that “[t]he Legislature should determine clearly in law who is the owner of medical records”).
31. See discussion infra Part II; see also Hall & Schulman, supra note 27, at 1282 (acknowledging that “the effect of other legal regimes may sometimes resemble property
law”).
32. See Abraham Bell & Gideon Parchomovsky, Pliability Rules, 101 MICH. L. REV. 1
(2002). The important feature of pliability rule protection, for purposes of this discussion, is
that it offers a dynamic scheme of entitlements in which a baseline rule of consensual ordering of data access can shift to nonconsensual access under specified circumstances. See id.
at 5 (“Pliability, or pliable, rules are contingent rules that provide an entitlement owner with
property rule or liability rule protection as long as some specified condition obtains; however, once the relevant condition changes, a different rule protects the entitlement — either
liability or property, as the circumstances dictate. Pliability rules, in other words, are dynamic rules, while property and liability rules are static.”).
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Much Ado About Data Ownership
75
data, and the grounds for nonconsensual data use are substantively
similar under either regime. This similarity suggests that property
rights may not be the right locus for reform. Creating property rights
in data would produce a new scheme of entitlements that is substantively similar to what already exists, thus perpetuating the same frustrations all sides have felt with the existing federal regulations.
Part III challenges the claim that clarifying data ownership would
improve access to useful data resources for clinical care, public
health,33 and research. This claim was central to the recent debate between Professors Hall and Schulman34 and Professor Rodwin,35 who
disagreed whether private or public ownership of patients’ data would
better promote data access. Data propertization proposals fail because
patients’ raw health information is not in itself a valuable data resource, in the sense of being able to support useful, new applications.36 Creating useful data resources requires significant inputs of
human and infrastructure services, and owning data is fruitless unless
there is a way to acquire the necessary services.37 Part IV considers
the impact of the 2009 Health Information Technology for Economic
and Clinical Health (“HITECH”) Act,38 which authorized data holders39 to supply the needed services commercially, subject to regulated
33. Public health data uses include tracking the spread of communicable diseases, reporting injuries that suggest child abuse, and conducting postmarket surveillance to monitor the
safety of approved drugs. See LAWRENCE O. GOSTIN, PUBLIC HEALTH LAW 4 (2d ed. 2008)
(characterizing public health law as focusing on population-oriented (as opposed to patientspecific) efforts “to ensure the conditions for people to be healthy (to identify, prevent, and
ameliorate risks to health in the population)” and “to pursue the highest possible level of
physical and mental health in the population, consistent with the values of social justice”);
Paul J. Amoroso & John P. Middaugh, Research vs. Public Health Practice: When Does a
Study Require IRB Review?, 36 PREVENTIVE MED. 250, 250 (2003) (providing as examples
of public health activities mandatory reporting of communicable diseases, investigating
disease outbreaks, and collecting confidential information by public health authorities to
protect the public health); Evans, supra note 25, at 589, 614–18 (discussing postmarket drug
safety surveillance and its character as a public health activity).
34. See Hall, supra note 23; Hall & Schulman, supra note 27.
35. See Rodwin, supra note 23; Rodwin, supra note 28.
36. See discussion infra Parts III.A–III.C.
37. See discussion infra Part III.D.
38. 42 U.S.C.A. §§ 17931–17940 (West 2010 & Supp. 2011).
39. “Data holder” is one of many names for entities — such as physicians, hospitals, insurers, and other health database operators — that possess individuals’ health data. See
FDA’s Sentinel Initiative, U.S. FOOD & DRUG ADMIN., http://www.fda.gov/Safety/
FDAsSentinelInitiative/ucm2007250.htm (last visited Dec. 21, 2011). But see JANET M.
MARCHIBRODA, EHEALTH INITIATIVE FOUND., DEVELOPING A GOVERNANCE AND
OPERATIONS STRUCTURE FOR THE SENTINEL INITIATIVE 21, 34 (2009), available at
http://www.regulations.gov/#!documentDetail;D=FDA-2009-N-0192-0006 (using “data
environment” and “data source”); Meryl Bloomrosen & Don Detmer, Advancing the
Framework: Use of Health Data — A Report of a Working Conference of the American
Medical Informatics Association, 15 J. AM. MED. INFO. ASS’N. 715, 715 (2008) (preferring
“data steward”).
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Harvard Journal of Law & Technology
[Vol. 25
pricing.40 This approach, which draws on a long tradition of successful American infrastructure regulation, offers promise in resolving
infrastructure bottlenecks, which — rather than the unresolved status
of data ownership — have presented the key impediment to data
availability.41
Despite this progress, important problems remain unresolved. A
major challenge in twenty-first century privacy law and research ethics will be to come to terms with the inherently collective nature of
knowledge generation in a world where large-scale informational research is set to play a more prominent role.42 Informational research
differs starkly from interventional research, exemplified by randomized, controlled clinical trials,43 which were the major workhorse of
late twentieth-century biomedical discovery.44 A person’s refusal to
participate in a clinical trial does not jeopardize the broader clinical
research enterprise, which can move forward using other willing research subjects; only 600–3000 people are needed for a typical clinical drug trial.45 In contrast, a person’s refusal to participate in
informational research may bias the dataset and reduce its statistical
power for everyone.46 Many important types of informational research
must be done collectively with large, inclusive datasets.47 An individual’s wish not to participate, perhaps motivated by privacy concerns,
potentially places other human beings at risk and undermines broader
public interests — for example, in public health or medical discovery — in which the individual shares.48 Existing regulations lack tools
to resolve this complex dilemma.
40. See discussion infra Part IV.
41. See discussion infra Parts III and IV.
42. See 21 U.S.C.A. § 355(o)(3)(D) (West. 2010 & Supp. 2011) (placing the U.S. Food
and Drug Administration under a requirement to consider and reject the use of observational
studies before the agency can order a postmarket clinical drug trial); ROUNDTABLE ON
EVIDENCE-BASED MED., INST. OF MED., THE LEARNING HEALTHCARE SYSTEM: WORKSHOP
SUMMARY 128, 130 (LeighAnne Olsen et al. eds., 2007) [hereinafter IOM, LEARNING
HEALTHCARE] (discussing the growing use of observational methodologies); Barbara J.
Evans, Seven Pillars of a New Evidentiary Paradigm: The Food, Drug, and Cosmetic Act
Enters the Genomic Era, 85 NOTRE DAME L. REV. 419, 479–85 (2010) (same).
43. See FRIEDMAN ET AL., supra note 15, at 2 (noting that clinical trials involve the use of
intervention techniques); FURBERG & FURBERG, supra note 9, at 11–22 (discussing randomized, controlled clinical trials).
44. See Evans, supra note 42, at 432 (noting that randomized, controlled clinical trials
played a central role in the mid-twentieth-century drug approval paradigm that the FDA
implemented under the 1962 Drug Amendments).
45. COMM. ON THE ASSESSMENT OF THE U.S. DRUG SAFETY SYS., INST. OF MED., THE
FUTURE OF DRUG SAFETY 36 (Alina Baciu et al. eds., 2007), available at
http://books.nap.edu/openbook.php?record_id=11750.
46. See discussion infra Part III.C.
47. Id.
48. See Paul Starr, Health and the Right to Privacy, 25 AM. J.L. & MED. 193, 200 (1999)
(noting that patients not only have an interest in the privacy of their health records, but also
have an interest in research and other efforts to improve the medical care available to them).
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Much Ado About Data Ownership
77
Part V identifies two fundamental defects of the current HIPAA
Privacy Rule and Common Rule. First, these regulations conceive the
state’s police power to use data to promote public health much more
narrowly than the police power is conceived in all other legal contexts. This has the effect of thwarting legitimate uses of data to improve the public’s health. Second, the existing provisions for
approving nonconsensual research uses of data fail to incorporate any
public use requirement — that is, a requirement that unconsented data
uses must be justified by a publicly beneficial purpose. As things
stand, persons whose health data are used in research have no assurance that the use will serve any socially beneficial purpose at all.49
The 2009 IOM recommendations,50 the more recent ANPRM,51 and
the ongoing clamor of data propertization proposals all fail to address
these problems. Reaping the full benefit of interoperable health information systems requires coming to grips with them. It is time to
reframe the debate. The right question is not who owns health data,
nor is it any of the seventy-four queries that erupted from the recent
ANPRM. Instead, the debate should be about appropriate public uses
of private data and how best to facilitate these uses while adequately
protecting individuals’ interests.
II. WHY DATA OWNERSHIP WOULD NOT PROTECT PATIENTS’
PRIVACY
A. Nonconsensual Access to Patient Data Under a Property Regime
Data propertization proposals fall into two broad categories: proprivacy proposals that portray private ownership as a way to bolster
patients’ power to block unwanted uses of their data and pro-access
proposals that aim to promote wider availability of data for clinical,
research, and public health uses.52 The pro-privacy proposals rest on a
mythical view of private property. Three centuries ago, Sir William
Blackstone noted how the human imagination is drawn to the idea of
property as “that sole and despotic dominion which one man claims
and exercises over external things of the world in total exclusion of
49. See discussion infra Part V.B (explaining the complete absence of a public use requirement in the Common Rule and HIPAA waiver provisions, which allow nonconsensual
access to data for research).
50. IOM, PRIVACY REPORT, supra note 3, at 28–29 (summarizing the IOM’s recommendations).
51. HHS, ANPRM, supra note 5.
52. See supra notes 23, 26–28 and accompanying text (providing examples of various
pro-privacy and pro-access proposals).
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the right of any other individual in the universe.”53 This idea resonates
with the “autonomy über alles” strand of privacy advocacy that asserts that a patient’s right to control access to health data should trump
all other interests, even society’s interest in conducting studies that
might save or improve other people’s lives.54 Blackstone, however,
was merely describing how people imagine property. He himself did
not espouse this view,55 nor has American law ever done so.56
Different assets call for different forms of ownership, and proponents of patient data ownership do not always specify what they have
in mind.57 Data ownership might, for example, need to look something like the nonexclusive rights riparian owners have in a river that
runs by their land — a right to use the river oneself but not to interfere
with others’ simultaneous uses for fishing and navigation58 — or like
a copyright, which expires after a fixed term of years and allows fair
use by others even during that term.59 Pro-privacy proposals seem to
draw on the ideal of property reflected in the saying, “one’s home is
one’s castle.”60 In the usual course of events, access to a person’s
home requires a consensual transaction with the owner, and unconsented uses can be enjoined.61 This package of rights and remedies
53. 2
WILLIAM
BLACKSTONE,
COMMENTARIES
*2,
available
at
http://avalon.law.yale.edu/18th_century/blackstone_bk2ch1.asp (spelling conformed to
modern conventions).
54. See Standards for Privacy of Individually Identifiable Health Information, 65 Fed.
Reg. 82,462, 82,698 (Dec. 28, 2000) (codified as amended at 45 C.F.R. pts. 160, 164) (noting in the preamble to the HIPAA Privacy Rule that some public comments had opposed
waiver provisions that would have let data be used without consent when “the research is of
sufficient importance so as to outweigh the intrusion of the privacy of the individual whose
information is subject to the disclosure,” and providing an example of one pro-autonomy
commenter who insisted that “common purposes should not override individual rights in a
democratic society”).
55. 1 BLACKSTONE, supra note 53, at *119, available at http://avalon.law.yale.edu/
18th_century/blackstone_bk1ch1.asp (recognizing that rights include both rights that are
owed to individuals and those that are “due from every citizen, which are usually called
civil duties” (spelling conformed to modern conventions)).
56. See Eric R. Claeys, Kelo, the Castle, and Natural Property Rights, in PRIVATE
PROPERTY, COMMUNITY DEVELOPMENT, AND EMINENT DOMAIN 35, 40–43 (Robin Paul
Malloy ed., 2008) (discussing the natural rights theory reflected in eighteenth- and nineteenth-century American takings jurisprudence and how it allowed interference with property rights under certain circumstances).
57. See, e.g., Hall, supra note 23, at 663 (calling for an unspecified “right mix and forms
of property rights among patients, providers, researchers, and compilers”).
58. See Eric R. Claeys, Takings, Regulations, and Natural Property Rights, 88 CORNELL
L. REV. 1549, 1591–93, 1596, 1600–02 (2003) (discussing cases that have addressed conflicts between riparian owners’ rights to build dams, mills, wharves, and other structures and
the need to preserve other uses such as navigation and fishing).
59. Abraham Bell, Private Takings, 76 U. CHI. L. REV. 517, 541 (2009).
60. Claeys, supra note 56, at 35–36 (discussing the popular meaning of the castle metaphor).
61. Thomas W. Merrill, The Economics of Public Use, 72 CORNELL L. REV. 61, 64
(1986) (discussing rights and remedies available under a scheme of property-rule protection).
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corresponds to property-rule protection,62 and it is what privacy proponents seem to be seeking in their calls for data ownership: consensual ordering of data access and the power to stop unconsented uses.
The fatal flaw in pro-privacy proposals is this: having a property
right does not ensure property-rule protection. Law recognizes that
there are many situations where consensual transactions cannot be
relied on as a way of ordering an owner’s relations with the larger
community.63 In many circumstances, a property owner only receives
liability-rule protection,64 which means the owner can be forced to
give up her property in return for compensation that is externally set,
often by a court, legislature, or administrative agency.65 That compensation may be zero. The government — when acting under its police
power to protect the public’s health, safety, morals, or welfare — has
broad power to confiscate or interfere with property without compensating the owner.66 Dating back to colonial times, the state’s police
power has been used not just to prevent property owners from injuring
others, but also to pursue broader public welfare objectives for the
benefit of the community.67 “[T]here was no single paradigm of public welfare that confined what we now call the police power. Then, as
now, lawmakers pursued a shifting amalgam of goals . . . . Legislation
coercively promoted uses of private land that were viewed as conducive to the community’s well-being.”68 Consistent with this tradition,
the government can require nonconsensual access to data for use in
public health activities, which long have been viewed as a legitimate
exercise of the state’s police power.69 This would remain true even if
data were patient-owned.
62. Guido Calabresi & A. Douglas Melamed, Property Rules, Liability Rules, and Inalienability: One View of the Cathedral, 85 HARV. L. REV. 1089, 1092 (1972).
63. See id. at 1108–09 (discussing the problems with relying on consensual transactions
to compensate for accidents); Bell & Parchomovsky, supra note 32, at 8–19 (discussing the
evolution of entitlement theory as it bears on the relative merits of consensual and nonconsensual ordering in various circumstances).
64. Calabresi & Melamed, supra note 62, at 1092.
65. Bell & Parchomovsky, supra note 32, at 3.
66. See Merrill, supra note 61, at 66 (“[T]he government [can] take [a citizen’s] property
without his consent and without compensation . . . when the government legitimately exercises its power to tax or its police power.”).
67. See, e.g., John F. Hart, Land Use Law in the Early Republic and the Original Meaning of the Takings Clause, 94 NW. U. L. REV. 1099, 1102 (2000); id. at 1107 (discussing
historical uses of the state’s police power to require owners to confer positive externalities
on the community); William Michael Treanor, The Original Understanding of the Takings
Clause and the Political Process, 95 COLUM. L. REV. 782, 797 (1995) (same).
68. Hart, supra note 67, at 1107.
69. Hall, supra note 23, at 659 (noting that the government currently requires disclosure
of identifiable information for public health purposes under its police power); see also
GOSTIN, supra note 33, at 11 (“Public health has historically constrained the rights of individuals and businesses so as to protect community interests in health . . . [including] the use
of reporting requirements affecting privacy . . . .”); Wendy E. Parmet, After September 11:
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The state also has eminent domain power to take property for
“public use”70 without the owner’s consent, subject to payment of just
compensation.71 The public uses that can support a taking are quite
broad and could include private, commercial research uses of data, if
data were patient-owned. Takings require “some showing of ‘publicness’” of the intended use,72 and takings that lack the requisite public
quality can be enjoined.73 Public uses traditionally involved placing
the property under public ownership or transferring it to a private
company, such as a utility or railroad, that is obligated to serve the
public, often but not always for a regulated price.74 There was never a
requirement that the fruits of a taking be made freely available to the
public: railroads and stadiums built on taken land routinely require
users to buy tickets.75 Modern courts, somewhat controversially,76
allow takings that transfer property to new private owners for commercial projects that need not be open to the general public77 and for
projects that offer only indirect public benefits, such as boosting local
tax revenues or aiding urban renewal or land reform.78
The possibility of eminent domain appears to have been lost on
privacy advocates who view data ownership as a way to halt unconsented, private-sector research use of data. Modern takings doctrine
Rethinking Public Health Federalism, 30 J.L. MED. & ETHICS 201, 202–03 (2002) (discussing the police power to protect public health).
70. See Robin Paul Malloy & James Charles Smith, Private Property, Community Development, and Eminent Domain, in PRIVATE PROPERTY, COMMUNITY DEVELOPMENT, AND
EMINENT DOMAIN, supra note 56, at 1, 8 (discussing the public use requirement).
71. U.S. CONST. amend. V.
72. Merrill, supra note 61, at 61.
73. Id. at 68, 85.
74. See Kelo v. City of New London, 545 U.S. 469, 479 (2005) (“[M]any state courts in
the mid-nineteenth-century endorsed ‘use by the public’ as the proper definition of public
use . . . .”); see also Claeys, supra note 56, at 42–43 (discussing early cases that applied
natural rights theory to limit the use of eminent domain to situations where the taken property would go “to a state agency, or to a private entity with standard common-carrier duties of
non-discrimination and reasonable rates”); Bell, supra note 59, at 552 (“[P]ublic ownership
of the taken property is not a necessary companion to just and efficient takings . . . .”).
75. See Brett M. Frischmann, An Economic Theory of Infrastructure and Commons Management, 89 MINN. L. REV. 917, 925–26 (2005).
76. See Michael Allan Wolf, Hysteria Versus History: Public Use in the Public Eye, in
PRIVATE PROPERTY, COMMUNITY DEVELOPMENT, AND EMINENT DOMAIN, supra note 56,
at 15, 15–20 (discussing public reaction to cases that have relied on a broader public purpose test).
77. See, e.g., Kelo, 545 U.S. at 472–75, 484 (allowing homes to be transferred to private
corporations for use in constructing an office park that, when completed, would be available
to commercial tenants rather than to the general public); Poletown Neighborhood Council v.
City of Detroit, 304 N.W.2d 455, 459–60 (Mich. 1981) (allowing property to be taken for
development of a private manufacturing plant).
78. See, e.g., Kelo, 545 U.S. at 472 (allowing taking for purpose of generating tax revenue); Haw. Hous. Auth. v. Midkiff, 467 U.S. 229 (1984) (allowing taking for purpose of
land reform); Berman v. Parker, 348 U.S. 26 (1954) (allowing taking for purpose of urban
renewal).
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would allow privately owned health data to be taken for use in academic and commercial research that offers a prospect of developing a
beneficial therapy. This is true even if the new therapy, when successfully developed, would be available only to patients who can pay for
it. It seems doubtful that patients would be entitled to compensation
when their data were taken for use in research. Courts construe “just
compensation” to mean payment of market value79 — what the property would fetch in an alternative, consensual sale on the open market.80 There is no compensation for subjective value, such as the
emotional attachment an owner has to a particular home, or for undeveloped use rights — what the undeveloped property might have been
worth if the current owner had chosen to develop it.81 There also is no
compensation for consequential costs of the taking, such as an owner’s moving expenses.82 These same limitations presumably would
apply if patient-owned data were taken for public use in research.
When patients wish to have their data “lie fallow” because of privacy
concerns, the fair market value of the data arguably is zero: if patients
oppose having their data used in research at all, there is no alternative
consensual use by which to gauge the data’s market value. The value
of unused data is largely subjective, reflecting an emotional attach-
79. See Abraham Bell & Gideon Parchomovsky, The Hidden Function of Takings Compensation, 96 VA. L. REV. 1673, 1677 (2010) (noting that eminent domain only compensates market value, not emotional attachment or subjective valuation).
80. See Merrill, supra note 61, at 83 (noting that compensation is assessed relative to the
property’s fair market value “in its highest and best use other than the use proposed by the
condemnor”).
81. Id.; see also Claeys, supra note 58, at 1646–47 (noting that takings compensation is
based on adverse economic impact in the form of interference with “distinct investmentbacked expectations” (citing Penn Central Transp. Co. v. City of New York, 438 U.S. 104,
124 (1978))).
82. See Merrill, supra note 61, at 83 (“[O]ther personal losses which do not ‘run’ with the
property, such as lost goodwill, consequential damages to other property, relocation costs,
and attorney fees, are also not compensable.”); Frank I. Michelman, Property, Utility, and
Fairness: Comments on the Ethical Foundations of “Just Compensation” Law, 80 HARV. L.
REV. 1165, 1254 (1967) (“When land is appropriated for clearance and redevelopment, its
owner is, of course, compensated in the amount of its ‘fair market value.’ But, by the generally received doctrines, . . . tenant-owners are not constitutionally entitled to be compensated for the disruptive effects of changing neighborhoods and sinking new roots, or even,
in case a business is uprooted, for good will destroyed, or, very possibly, for the cash outlay
entailed in moving.”). But see Malloy & Smith, supra note 70, at 8 (noting that some jurisdictions may adjust compensation in light of relocation expenses and costs to acquire substitute property).
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ment to the data and a wish to keep it secret.83 This is not compensable under modern takings doctrine.84
B. Nonconsensual Data Access Under the Existing Federal
Regulations
The HIPAA Privacy Rule and the Common Rule offer a framework of patient entitlements and protections that is strikingly similar
to what patients would enjoy if they owned their data. Under ordinary
circumstances, both regulations require consensual ordering of data
access: they require a privacy authorization85 or informed consent86
before data can be used. However, both regulations contain exemptions, exceptions, and definitional nuances that shift to a regime of
liability-rule protection under certain circumstances.87 The recent
ANPRM would adjust specific provisions but preserve this same
overall structure.88
Under the current regulations, certain activities that are considered to have high social value — such as using data for judicial, law
enforcement, and public health purposes — are not subject to the usual consent and authorization requirements.89 Nonconsensual research
83. See, e.g., ALAN F. WESTIN, HOW THE PUBLIC VIEWS PRIVACY AND HEALTH
RESEARCH 13 (2007) (suggesting that the fifty percent of surveyed individuals who expressed concern about research access to their health data “are expressing the ‘pure privacy’
position — a sense of violation or intrusion if their sensitive health information is seen by
an unknown third party, . . . even if a promise of anonymity is offered; and even if no actual
harm to reputation is likely to result from such research activity”).
84. See Hall, supra note 23, at 659; Rodwin, supra note 23, at 609. Hall and Rodwin both
argue that patients have no property interest in de-identified data; therefore, research uses of
such data would not constitute a taking and, hence no compensation would be owed. My
point is different: even if the data were identifiable or fully identified, and even if the patient
had a property interest in the data, and even if research use of the data were deemed to be a
taking, it is still true that no compensation would be owed, because takings doctrine does
not compensate subjective value — and the perceived value of keeping data unutilized is a
subjective value.
85. See 45 C.F.R. § 164.508 (2010) (describing authorization requirements of the HIPAA
Privacy Rule).
86. Id. § 46.116 (describing informed consent requirements of the Common Rule).
87. See id. § 164.512 (describing exceptions to the HIPAA Privacy Rule’s authorization
requirements); see also id. § 46.101(b)–(d) (describing exemptions to the Common Rule);
id. § 46.102(d), 46.102(f) (defining the terms “research” and “human subject”); OHRP
Guidance, supra note 10 (“OHRP does not consider research involving only coded private
information or specimens to involve human subjects as defined under 45 C.F.R.
§ 46.102(f) . . . .”).
88. See, e.g., HHS, ANPRM, supra note 5, at 44,518–21, 44,527 tbl.1 (proposing to require consent for certain exempt data uses that do not presently require consent under the
Common Rule). But see id. at 44,523–25 (contemplating circumstances under which consent requirements could still be waived); id. question 24, at 44,521 (seeking public comment
on whether certain high-valued activities, such as quality improvement and public health
activities, should lie outside the Common Rule’s consent requirements).
89. See Barbara J. Evans, Issue Brief: Appropriate Human-Subject Protections for Research Use of Sentinel System Data, FDA SENTINEL INITIATIVE MEETING SERIES: LEGAL
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use of data is allowed under conditions aimed at reducing privacy
risks to the data subjects. Such use is allowed if the data have been deidentified,90 coded in compliance with specified standards,91 or converted to a limited data set.92 Nonconsensual research uses are also
allowed if an Institutional Review Board or privacy board (collectively, “IRB”)93 approves a waiver of the usual consent or authorization
requirements.94 Data supplied to researchers under a HIPAA waiver
must meet “minimum necessary”95 requirements — i.e., no more information can be disclosed than is necessary to accomplish the intended research purpose. However, there is no requirement that the
data be de-identified or even coded to qualify for a waiver. In theory,
it is possible to disclose fully identified data under a waiver, if the
ISSUES IN ACTIVE MEDICAL PRODUCT SURVEILLANCE 4 (Mar. 2010), available at
http://www.brookings.edu/~/media/Files/events/2010/0308_FDA_legal_issues/Panel%203
%20Issue%20Brief.pdf (summarizing the various pathways for nonconsensual use of data
under the HIPAA Privacy Rule and the Common Rule); Evans, supra note 25, at 597, 619–
22 (describing the provisions for nonconsensual data access under the HIPAA Privacy
Rule); id. at 625–30 (describing nonconsensual access to data under the Common Rule and
under the FDA’s human subject protection regulations); see also Kristen Rosati, An Analysis
of Legal Issues Related to Structuring FDA Sentinel Initiative Activities, U.S. FOOD &
DRUG ADMIN. (2009), available at http://www.regulations.gov/#!documentDetail;D=FDA2009-N-0192-0003 (providing a detailed examination of provisions of the Privacy Rule,
Common Rule, the Privacy Act, and other relevant laws — such as those governing data on
substance abuse — that affect access to data used in FDA’s postmarket drug safety surveillance activities).
90. See 45 C.F.R. § 164.514(b) (2010) (allowing data to be de-identified, for purposes of
HIPAA, by removing eighteen specific types of identifiers or by having a statistician certify
that the risk of re-identification is “very small”); id. § 46.102(f) (defining “human subject”
in a way that means that research with data is not covered by the Common Rule’s consent
requirements if investigators do not receive identifying information or interact with the
subjects). But see HHS, ANRPM, supra note 5, at 44,519, 44,523 (requiring consent for
some uses of de-identified data that would not require consent under the existing Common
Rule).
91. See 45 C.F.R. § 164.514(c) (2010) (allowing coded data to be considered “deidentified” under the HIPAA Privacy Rule if the code key is subject to certain restrictions
on derivation and access); OHRP Guidance, supra note 10 (discussing permissible coding
arrangements under the Common Rule).
92. Id. § 164.514(e).
93. See 45 C.F.R. §§ 46.103(b), 46.107–108 (2010) (describing IRBs: private ethical review panels, often staffed by employees of the data holder or data-using research institution,
to which the Common Rule delegates various aspects of research oversight); id.
§ 164.512(i)(2)(iv) (allowing of waivers of consent under the HIPAA Privacy Rule to be
approved by either a Common Rule-compliant IRB or by a HIPAA-compliant “privacy
panel” that is similar to an IRB); see also Evans, supra note 25, at 622–25 (discussing and
critiquing the role of IRBs in approving consent waivers).
94. 45 C.F.R. § 164.512(i) (2010) (HIPAA waiver provision); id. § 46.116(d) (Common
Rule waiver provision).
95. 45 C.F.R. § 164.514(d) (2010).
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research requires the use of identified data and if an IRB deems the
other waiver conditions to be met.96
While some people object to any nonconsensual use of their data,
there is fairly solid public support for police power uses of data —
such as monitoring the spread of epidemics — that protect public
health, safety, and welfare.97 The public also has some degree of comfort with the use of de-identified and other “masked” forms of data98
despite ongoing concerns about the potential for such data to be reidentified.99 Waivers do not inspire similar levels of public understanding.100 They are subject to ongoing critique from research institutions and IRBs that find the waiver provisions cumbersome to
apply101 and from scholars and privacy advocates who view them as
an abuse-prone bypass to consent requirements.102
The waiver provisions of the HIPAA Privacy Rule and the Common Rule are best understood as a regulator-created analogue of private takings power. These provisions let private bodies (IRBs) apapprove nonconsensual research use of data.103 There is a long history
in the United States, dating back to colonial times, of delegating takings power to private parties — such as developers of milldams and
railroads — so that they can take property directly for socially benefi96. See Barbara J. Evans, Ethical and Privacy Issues in Pharmacogenomic Research, in
PHARMACOGENOMICS: APPLICATIONS TO PATIENT CARE 313, 331 (Howard L. MacLeod et
al. eds., 2d ed. 2009).
97. See IOM, PRIVACY REPORT, supra note 3, at 82.
98. Id.
99. See FED. TRADE COMM’N, PROTECTING CONSUMER PRIVACY IN AN ERA OF RAPID
CHANGE: A PROPOSED FRAMEWORK FOR BUSINESSES AND POLICYMAKERS 35–38 (2010)
(warning that the distinction between personally identifiable information and nonidentifiable information is increasingly irrelevant in light of the potential for data to be reidentified); Paul Ohm, Broken Promises of Privacy: Responding to the Surprising Failure of
Anonymization, 57 UCLA L. REV. 1701, 1706 (2010) (discussing the risks to individual
privacy if de-identified data were to be re-identified); Mark A. Rothstein, Is Deidentification
Sufficient to Protect Health Privacy in Research?, 10 AM. J. BIOETHICS 3, 5 (2010) (“Despite using various measures to deidentify health records, it is possible to reidentify them in
a surprisingly large number of cases . . . .”). But see Deven McGraw, Data Identifiability
and Privacy, 10 AM. J. BIOETHICS 30, 30 (2010) (“Using information in less identifiable
form greatly reduces risks to privacy . . . .”); Daniel A. Moros and Rosamond Rhodes, Privacy Overkill, 10 AM. J. BIOETHICS 12, 13 (2010) (“There is no evidence to suggest, and no
obvious reason to suppose . . . that the current protections of deidentified research information are inadequate.”).
100. Evans, supra note 25, at 624.
101. See supra notes 3, 5.
102. See Carl H. Coleman, Rationalizing Risk Assessment in Human Subject Research,
46 ARIZ. L. REV. 1, 13–17 (2004) (discussing procedural informality of the Common Rule);
see also Evans, supra note 96, at 332 (discussing procedural informality of the waiver provisions of the Common Rule and HIPAA Privacy Rule); Evans, supra note 89, at 5 (same);
Evans, supra note 25, at 624–25 (same).
103. See Barbara J. Evans, Authority of the Food and Drug Administration to Require
Data Access and Control Use Rights in the Sentinel Data Network, 65 FOOD & DRUG L.J.
67, 102–06 (2010) (discussing the role of IRBs in approving access to data under waiver
provisions of the Common Rule and HIPAA Privacy Rule).
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cial uses without having the government act as an intermediary.104
Modern examples include private development corporations, which
city and state governments sometimes empower to assemble parcels
of land for planned redevelopment projects.105
The HIPAA and Common Rule waiver provisions are criticized
on various grounds,106 but the fact remains that there are strong justifications for granting private actors at least some power to approve
nonconsensual data access. Private delegations of eminent domain
power are justified under three circumstances, all of which are present
in the area of informational research. First, they make sense when
there are holdouts or other strategic barriers to consensual transactions107 — in other words, when obtaining consent is “impracticable,”108 which happens to be one of the conditions109 for granting a
waiver of patient consent under the HIPAA Privacy Rule and the
Common Rule. Second, private takings are appropriate in situations
where justice and efficiency are better served by transferring the taken
property to a subsequent private owner rather than to the government.110 This is the case, for example, if a private-sector research institution has a greater capability for unlocking the scientific and
public health potential of the data than government agencies possess.111 Third, private takings make sense when a repeated pattern of
104. See Bell, supra note 59, at 517 (“[P]rivate takings — that is, takings carried out by
nongovernmental actors — have a solid basis in our legal system.”); id. at 545, 549–50
(providing examples of delegated private takings); Hart, supra note 67, at 1116–17
(“[M]ill acts are a well-known illustration of the state's power to direct the transformation of
particular pieces of land in America by delegation of its power to private persons.”).
105. Bell, supra note 59, at 549–50.
106. See supra note 102 (citing procedural critiques); see also discussion infra Part V.B
(discussing the absence of a criterion requiring nonconsensual research uses of data to provide public benefits).
107. See Bell, supra note 59, at 538–40, 543.
108. See 45 C.F.R. § 164.512(i)(2)(ii)(B)–(C) (2010) (requiring impracticability both of
obtaining consent and of conducting the research without access to the data, before a
HIPAA waiver can be granted); id. § 46.116(d)(3) (requiring impracticability of conducting
the research without a Common Rule waiver).
109. 45 C.F.R. § 164.512(i)(2)(ii) (2010) (stating HIPAA waiver criteria); id. § 46.116(d)
(stating Common Rule waiver criteria).
110. See Bell, supra note 59, at 534 (suggesting that the takings power is warranted only
if “the government is the preferred owner for reasons of justice or efficiency”).
111. See U.S. FOOD & DRUG ADMIN., ADVANCING REGULATORY SCIENCE FOR PUBLIC
HEALTH, available at http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/
Reports/BudgetReports/UCM207395.pdf (“During the past two decades, extraordinary
investments have led to revolutionary advances in the biomedical sciences. However,
FDA’s scientific expertise and infrastructure have not kept pace with these advances. . . .
FDA is unable to fulfill its mission, in part because it lacks modern scientific expertise.”);
U.S. FOOD & DRUG ADMIN., THE CRITICAL PATH INITIATIVE: REPORT ON KEY
ACHIEVEMENTS IN 2009, available at http://www.fda.gov/downloads/ScienceResearch/
SpecialTopics/CriticalPathInitiative/UCM221651.pdf at 1 (describing FDA’s Critical Path
Initiative, which is pursuing a “new paradigm” that is “building partnerships and creating
new opportunities for industry and other stakeholders to share expertise and data”); Pub-
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similar transactions makes government involvement administratively
burdensome.112 This condition arguably is met in the current era of
heavy reliance on informational research;113 the waiver provisions
avoid bottlenecks that could arise if the government acted as an intermediary in every nonconsensual research use of data.
Under a property regime, patients’ ability to control uses of their
data might be very similar to the substantive entitlements they enjoy
under the existing federal regulations. There could, of course, be procedural differences, with the property regime imposing higher “due
process” costs114 on nonconsensual uses of data. Yet high due process
costs are themselves a factor that tends to justify private delegations
of takings power. If patients owned their data, it is quite possible that
some scheme of private eminent domain — perhaps resembling the
waiver provisions of the federal regulations — would be necessary to
address the high due process costs of securing access to data. Based
on precedents in the railroad and utility industries,115 it would not be
out of line for the government to delegate eminent domain power to
private actors — such as healthcare data environments and research
institutions — that are repeatedly involved in transactions to supply or
acquire data for use in informational research. It is hard to make a
case that data ownership would give patients any more control than
they now have.
III. WHY DATA OWNERSHIP CANNOT RESOLVE DATA ACCESS
PROBLEMS
Turning to the pro-access proposals, the health information privacy community was puzzled recently by a debate in which several of
lic/Private Partnership Program, Biomarker Consortium (BC), U.S. FOOD & DRUG
ADMIN.,
http://www.fda.gov/AboutFDA/PartnershipsCollaborations/PublicPrivate
PartnershipProgram/ucm231115.htm (last visited Dec. 21, 2011) (describing a publicprivate partnership the FDA has formed with twenty-eight private corporations and thirtyfour independent research foundations and institutions to accelerate progress in biomarkerbased technologies).
112. See Bell, supra note 59, at 545, 561–62 (providing the example of utility companies
that have a need to conduct repeated transactions to acquire rights-of-way).
113. See Brian L. Strom, Preface to PHARMACOEPIDEMIOLOGY, supra note 9, at xvi (noting that epidemiological data are now routinely used in regulatory decision making); IOM,
LEARNING HEALTHCARE, supra note 42, at 129–30 (discussing the value and challenges of
observational methodologies); Evans, supra note 42, at 438–39 (attributing the growth of
information-based research after 1980 to various stimuli, including improvements in database technology); AHRQ, Fact Sheet, supra note 18 (discussing the rise and future directions of outcomes research).
114. See Merrill, supra note 61, at 77 (discussing the procedural complexity of eminent
domain, which imposes due process costs in the form of difficulties obtaining legislative
authority for a taking, drafting and filing the complaint, serving of process, securing a formal appraisal of the asset’s value, and potentially litigating trials and appeals).
115. Bell, supra note 59, at 545, 561–63; Hart, supra note 67, at 1102.
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our most admired scholars drew divergent conclusions about the optimal scheme of ownership for patient data. Divergent conclusions are
not puzzling in themselves, but they are so when two analyses that
embrace similar objectives, similar methodologies, and similar assumptions give rise to the divergence. Both analyses — one by Professors Hall and Schulman,116 the other by Professor Rodwin117 —
favor the objective of making health data more widely available for
use in medical treatment, public health, and research.118 Both employ
resource classification as their methodology — a method in which
analysts “classify infrastructure resources as public goods, network
goods, natural monopoly, or some combination thereof”119 to explain
why “markets may fail to efficiently supply such goods, and then proceed to analyze the form of institutional intervention by the government to correct the failure.”120 Both analyses state many of the same
assumptions: that the use of health data is nonrivalrous,121 health data
resources generate public goods,122 interoperable data systems exhibit
network effects,123 data holders such as insurers and healthcare providers enjoy rights somewhat equivalent to ownership of patient data
amid the present legal ambiguities,124 and control of data resources is
116. Professors Hall and Schulman argue in favor of patient ownership of health data.
See Hall & Schulman, supra note 27; see also Hall, supra note 23 (making similar arguments in a longer legal analysis).
117. Rodwin, supra note 23; Rodwin, supra note 28 (arguing for public ownership of deidentified patient data).
118. See Hall, supra note 23, at 635–36 (discussing the major challenge of creating “an
interconnected, automated, networked world where information follows the patient, information-based tools aid in decision making, and population health data can be mined to
improve the quality and outcome of care for all”); Rodwin, supra note 23, at 586–87 (summarizing the advantages of tapping data from patient records in order to “improve medical
knowledge, patient safety and public health”).
119. Frischmann, supra note 75, at 939–40.
120. Id. at 929, 939–41.
121. Hall, supra note 23, at 661 (“Information by its nature is nonrivalrous, meaning it
can be used by many people at once without depletion.”); see Rodwin, supra note 23, at 598
(noting that with public goods, “an individual’s use does not diminish use by another person”).
122. See Rodwin, supra note 23, at 597–98, 618; cf. Hall, supra note 23, at 643
(“[H]oarding medical information destroys the commons that might otherwise support valuable public goods.”).
123. Rodwin, supra note 23, at 597–98 (“Patient data display network effects.”); see also
Hall, supra note 23, at 638 (claiming that network effects emerge by connecting medical
records).
124. See Hall, supra note 23, at 646 (noting that information held by such entities is “out
of circulation even though it is not, strictly speaking, owned”); Rodwin, supra note 23, at
588 (noting that data holders “treat patient data as if it were their private property”); id. at
593 (asserting that “[i]f legislation does not resolve the ownership of data, courts are likely
to grant property interests to those who possess [patient] data and preserve the status quo”).
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highly fractured at the level of these data holders, leading to a tragedy
of the anticommons.125
Despite their similar approaches, the authors recommend starkly
different policy interventions. Rodwin calls for public ownership of
patients’ anonymized data.126 He argues “that treating patient data as
private property precludes forming comprehensive databases required
for many of its most important public health and safety uses” and proposes “that federal law require providers, medical facilities and insurers to report key patient data in anonymized and de-identified form to
public authorities, which will create aggregate databases to promote
public health, patient safety, and research.”127 Rodwin’s proposal is,
in effect, a scheme of nonconsensual access to patients’ anonymized
data, although he does not label it as such. Data holders, such as
healthcare providers and insurers, would be required by statute to report data to public authorities.128 Implicit in this scheme is that patients have no say in the matter. This nonconsensual ordering of data
access is a critical feature of Rodwin’s proposal.129
Hall and Schulman, on the other hand, call for consensual ordering of data access. They suggest that it would stimulate market development of interconnected electronic medical records (“I-EMRs”)130 if
patients had a right to enter commercial transactions to license access
to their medical information that is in the custody of insurers,
healthcare providers, and other data holders.131 In his longer analysis,
Hall argues that the U.S. healthcare system’s fragmentation is “chronic and deeply entrenched”132 such that patients’ medical information is
widely scattered among data holders who may lack incentives to develop I-EMRs. Patients have rights of access to their own data,133 but
in Hall’s view, lack clear entitlements to transfer these rights on
commercial terms to “compilers” that could assemble the patient’s
scattered data into I-EMRs. “If patients were given ownership of their
complete medical treatment and health histories, they could license to
compilers their rights to that information in a propertized form that
could be more fully developed and commercialized.”134
125. See Hall, supra note 23, at 647 (noting that the data holders’ “[m]ultiple ownership
of different pieces of a patient’s medical history . . . makes it difficult for anyone to assemble a complete record”); Rodwin, supra note 23, at 606 (discussing fracturing of control
over patient data at the level of physicians, hospitals, and insurers, and noting a second level
of fracturing of control at the level of individual patients).
126. Rodwin, supra note 28, at 86.
127. Rodwin, supra note 23, at 589.
128. Id.
129. See discussion infra Part III.C.
130. See Hall, supra note 23, at 636 (defining I-EMRs).
131. Id. at 638; see also Hall & Schulman, supra note 27, at 1283–84.
132. Hall, supra note 23, at 640.
133. Id. at 649–50.
134. Hall, supra note 23, at 651.
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Hall’s analysis is sometimes characterized as a call for private
ownership of data.135 It should not, however, be confused with the
demands for property rights sometimes voiced by privacy advocates
with the aim of blocking data access.136 Hall offers a nuanced analysis, recognizing that the precise scope of the patient’s entitlement
would need to be carefully defined and acknowledging a risk that giving patients additional legal rights could add new strategic barriers in
a market that already, in Hall’s view, exhibits an anticommons problem at the level of data holders.137 Hall and Schulman present their
proposal as “one potential solution.”138 Under their proposal, the patient would be able to grant a license to a trusted intermediary, which
in turn would be able to (1) compel the various data holders to make
the patient’s medical information available for compilation into an IEMR (subject, of course, to reimbursing the data holder’s costs of
complying with such requests)139 and (2) act as the patient’s agent for
purposes of arranging commercial transactions with third parties that
desire to use the patient’s I-EMR.140 The patient would control the
terms under which the trusted intermediary could license the patient’s
I-EMR to prospective data users, and patients would have a “nonwaivable right to revoke any permission they give for access or use.”141
This scheme of patient-controlled I-EMRs would differ from familiar
“ownership of houses and cars.”142
Both of these analyses are insightful and have advanced the
scholarly debate about data ownership, access, and privacy. The
comments offered here aim to build on, rather than quibble with, these
two proposals. This section examines why neither of the proposals
just discussed would fix the data access problem. To explain why these proposals fail, it is necessary to explore some of the implicit assumptions on which they rest. This section focuses on two basic
questions that can generate divergent assumptions. The first question
is, “What types of health data constitute useful data resources — in
135. See, e.g., Rodwin, supra note 23, at 608 (“Professor Mark Hall argues that private
ownership can overcome anticommons problems that block the adoption of integrated
EMRs and networks.”); Who Should Own Electronic Medical Records?, ALLBUSINESS
(2009), http://www.allbusiness.com/print/13276486-1-22eeq.html (labeling the Hall and
Schulman analysis as “the case for private ownership” and presenting it as “the opposing
view” to Rodwin’s “case for public ownership of data”).
136. See discussion supra Part II.
137. See Hall, supra note 23, at 646–47.
138. Hall & Schulman, supra note 27, at 1284.
139. Hall, supra note 23, at 650 (noting that the patient’s access to patient records held
by HIPAA-covered entities is subject to payment of fees to cover the costs of preparing and
copying the records, and offering that a “potential solution for the fee problem is insurance
reimbursement”).
140. Id. at 660–61.
141. Id. at 661.
142. Hall & Schulman, supra note 27, at 1282.
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other words, data in a form that can support useful applications in
clinical care, public health, and research?” Part III.A defines four categories of health data resources that differ markedly in their utility for
these various applications. The second question is, “How are useful
data resources made?” Making some types of data resource, as discussed in Part III.B, requires access to identifying information about
patients. Part III.C explains that making one particularly useful type
of data resource requires a scheme of nonconsensual access to patients’ data. Making data resources also requires significant inputs of
human and infrastructure services, as described in Part III.D. Simply
owning data will not ensure an adequate supply of data resources
without access to the necessary services. Proposals that fail to address
these realities cannot resolve the data access problem.
A. Identifying the Valuable Data Resources
In ordinary usage, terms like “medical information” and “health
data” can refer to several distinct types of information resource:
1. Records of a Patient’s Various Encounters with the Healthcare
System
This discussion will use the terms “encounter-level patient data”
or “raw patient health data” to refer to records of a patient’s various
encounters with the healthcare system, such as paper charts or electronic files stored by the healthcare providers, payers, clinical laboratories, pharmacies and other sellers of medical products with which
the patient has done business in the course of receiving healthcare.
Hall’s “medical information”143 and Rodwin’s “patient data”144 often
refer to encounter-level patient data. Hall’s electronic health records
(“EMR”) are electronic records of a patient’s encounters with a single
healthcare site, such as a hospital or a physician’s office.145
2. The Patient’s Longitudinal Health Record (“LHR”)
An LHR compiles a patient’s encounter-level data from disparate
sources to form an extended chronological record that tracks the patient’s illnesses, treatments, and outcomes over multiple encounters
with the healthcare system.146 Hall and Schulman refer to these as
143. Hall, supra note 23, at 646.
144. Rodwin, supra note 23, at 586.
145. Hall, supra note 23, at 643–44.
146. See Deborah Shatin, Nigel S.B. Rawson & Andy Stergachis, UnitedHealth Group,
in PHARMACOEPIDEMIOLOGY, supra note 9, at 271, 273 (discussing “longitudinal histories”
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“longitudinal patient records”147 or “a consolidated medical record for
each patient.”148 Hall’s I-EMRs would produce LHRs by “facilitat[ing] the compilation of a patient’s entire medical treatment and
health history from among multiple independent records holders.”149
3. Longitudinal Population Health Data (“LPHD”)
LPHD gathers LHRs from many patients to create a dataset that
reflects the long-term healthcare experiences of a large number of
people.150 Hall’s trusted intermediaries would be able to enter transactions that gather patient-specific LHRs together to form LPHD. Rodwin’s “national patient database” is intended to generate LPHD.
4. Unbiased LPHD
This is a subcategory of LPHD that, in addition to the characteristics just described, has a valuable attribute: the LPHD provides a representative sample151 of a larger population about which researchers
or public health authorities (together, “investigators”) are trying to
draw conclusions. The individual LHRs included in the unbiased
LPHD constitute a representative sample of a larger population of
interest. Studying unbiased LPHD will let investigators draw scientifically valid conclusions that are generalizable to that larger population.152 LPHD obviously is unbiased if it includes LHRs for all
members of the larger population in question, for example, if it includes data for all Americans or data for everyone in the world. Rodwin’s concept of “national, longitudinal patient data”153 is a form of
in which “[i]nformation on diagnosis, treatments, and the occurrence of adverse clinical
events, as coded on [insurance] claims, can be tracked across time”).
147. Hall & Schulman, supra note 27, at 1284.
148. Hall, supra note 23, at 635.
149. Id. at 651.
150. Evans, supra note 25, at 592.
151. See generally David M. Eddy, Should We Change the Rules for Evaluating Medical
Technologies?, in IOM, MODERN METHODS, supra note 24, at 117, 124–25 (discussing
various types of bias that can occur in scientific studies and their impact on generalizability
of results).
152. See FURBERG & FURBERG, supra note 9, at 35–36 (discussing problems that can affect data quality, including biases that can undermine the generalizability of results); infra
note 173 and accompanying text for discussion of empirical studies demonstrating biases
that can result when inclusion of individuals’ data into a dataset is predicated on informed
consent; see generally Brian L. Strom, Sample Size Considerations for Pharmacoepidemiology Studies, in PHARMACOEPIDEMIOLOGY, supra note 9, at 29, 30–35 (discussing the
sample sizes required for various types of health informational research); Suzanne L. West,
Brian L. Strom & Charles Poole, Validity of Pharmacoepidemiologic Drug and Diagnosis
Data, in PHARMACOEPIDEMIOLOGY, supra note 9, at 709 (discussing problems with data
quality in health informational research).
153. Rodwin, supra note 23, at 587.
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unbiased LPHD. Unbiased LPHD also can be created using smaller
samples of individuals’ LHRs, so long as a random, representative
sample is obtained. Hall’s statement that “population health data can
be mined to improve the quality and outcome of care for all”154 presumes the use of unbiased LPHD.
Encounter-level patient data and individual LHRs are useful for
purposes of treating the individual patient. For example, LHRs can
answer questions about a patient’s medical history that are relevant to
the current treatment encounter, or they can notify physicians about
treatments that other care providers have administered to the same
patient for the same illness so that duplicative or conflicting treatments can be avoided. Encounter-level patient data and individual
LHRs, which include data for just one person, have limited or no direct use as resources for public health studies and research, since it is
hard to draw general conclusions from the experiences of one person.155 However, encounter-level data and LHRs are raw material
from which useful data resources for research and public health can be
derived. The useful resource for public health and research activities
is LPHD.156 For the vast majority of research and public health studies, there is a further requirement to use unbiased LPHD that can support valid, generalizable scientific conclusions.157 There are some
research and public health applications that can work with biased
LPHD. For example, biased LPHD may be useful in preliminary studies to generate hypotheses for later, more rigorous study. In general,
however, research and public health studies that use LPHD need unbiased LPHD.
154. Hall, supra note 23, at 635–36.
155. See U.S. PREVENTIVE SERVS. TASK FORCE, GUIDE TO CLINICAL PREVENTIVE
SERVICES 862 (2d ed. 1996), available at http://odphp.osophs.dhhs.gov/pubs/
guidecps/PDF/APPA.PDF (comparing the quality of evidence produced by various methodologies and according the lowest ranking to opinions based on reports of outcomes in specific patient cases).
156. See PHARMACOEPIDEMIOLOGY, supra note 9, at Part III (containing a series of articles describing the types of data that are useful in various types of pharmacoepidemiological
studies); U.S. FOOD & DRUG ADMIN., SENTINEL NETWORK PUBLIC MEETING 51–56 (Mar.
7, 2007) (statement of Dr. Marc Overhage) [hereinafter FDA, MARCH 7 PROCEEDINGS],
available
at
http://www.fda.gov/ohrms/dockets/dockets/
07n0016/07n-0016-tr00001.pdf (discussing the importance and difficulty of linking data
longitudinally); U.S. FOOD & DRUG ADMIN., SENTINEL NETWORK PUBLIC MEETING 73–74
(Mar. 8, 2007) (statement of Dr. Clement McDonald) [hereinafter FDA, MARCH 8
PROCEEDINGS], available at http://www.fda.gov/ohrms/dockets/dockets/07n0016/07n-0016tr00002.pdf (discussing the importance of longitudinal population health data in research
and noting the difficulties of linking data from disparate data sources).
157. See discussion infra Part III.C.
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B. The Problem of Linking Data Across Healthcare Data
Environments
Rodwin calls for encounter-level patient data to be “anonymized
or de-identified”158 at the source by each data holder, which then
would report the anonymized data to a centralized, national database
that would somehow “create aggregate databases to promote public
health, patient safety, and research.”159 This proposal runs into a serious technical problem: it is impossible — not merely costly or difficult, but impossible — to make longitudinal health records out of
encounter-level patient data that have been anonymized.160 Linking
data longitudinally to create a patient’s LHR requires at least some
identifying information to establish that raw data received from various data holders relate to the same patient.161 If the goal is to make an
anonymized LHR, the order of operations matters: first, identifiable
encounter-level patient data are linked together to make an identifiable LHR; then the identifiable LHR is anonymized.162 The linkage
must precede the anonymization.
Rodwin’s proposal would let each data-holding facility report its
data in coded163 form — that is, with an individual tracking number
that allows data from the patient’s subsequent encounters with that
facility to be linked to data already reported.164 Unfortunately, these
facility-level tracking numbers would not let a patient’s data from one
facility be linked with data from other facilities where the patient has
received care.165 Each facility maintains its own coding system,166 and
a patient would be assigned different tracking numbers by the various
facilities with which she interacts. Sharing of code keys, which relate
the tracking numbers to specific individuals, amounts to sharing of
158. Rodwin, supra note 23, at 589.
159. Id.
160. See FDA, MARCH 7 PROCEEDINGS, supra note 156, at 51–56 (statement of Dr.
Overhage) (discussing the process of linking data longitudinally and noting the necessity for
some sharing of identifiable information); FDA, MARCH 8 PROCEEDINGS, supra note 156, at
73–74 (statement of Dr. MacDonald) (discussing the need for sharing of identifiable information to accomplish linkage); Evans, supra note 25, at 594–96, 606.
161. Evans, supra note 25, at 594–96, 606.
162. See Evans, supra note 103, at 77 fig.2 (explaining that longitudinal linkage requires
the use of at least some identifying information, such that de-identification must follow,
rather than precede, linkage).
163. See generally Evans, supra note 25, at 619–31 (discussing coding of data and its
significance under the HIPAA Privacy Rule, the Common Rule, and the FDA human subject protection regulations).
164. Rodwin, supra note 23, at 615.
165. See Evans, supra note 103, at 76–77 (discussing the difficulties with linking data
across multiple healthcare data environments).
166. FDA, MARCH 7 PROCEEDINGS, supra note 156, at 52–53 (statement of Dr. Marc
Overhage) (“Every institution typically has some kind of unique identifier for the individual
patient . . . [that] isn’t linked to anything else.”).
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identifiable data under the Privacy Rule and Common Rule.167 Rodwin’s proposal, which only allows sharing of de-identified patient
data, thus would not allow sharing of the code keys.
Suppose Mary Smith visits Dr. Brown for arthritis pain and is
prescribed rofecoxib (Vioxx). Two months later, she is treated at the
emergency department of Central Hospital for a stroke. Six months
later, she visits Dr. Brown again for a skinned knee. Under Rodwin’s
proposal, the national database would contain the following information: Dr. Brown treated anonymous patient 13275 for arthritis and
prescribed Vioxx. This same patient (identified by Dr. Brown’s tracking number 13275) was later treated for a skinned knee. Central Hospital treated anonymous patient 999345 for a stroke. There is no way
to link Mary’s data from Dr. Brown and Central Hospital into a complete LHR unless they divulge that tracking numbers 13275 and
999345 both refer to Mary Smith. If the data in the national database
are “mined” for information about Vioxx safety, investigators will see
a possible association between taking Vioxx and skinning one’s knee,
but they will not be able to detect the possible association between
taking Vioxx and having a stroke.
Under Rodwin’s proposal, the national database would not be
able to compile LHRs for each patient, since it would lack the identifying information needed to link the patient’s encounters across multiple facilities and data holders. Unable to create LHRs, the national
database could not produce the “[n]ational, longitudinal patient data”168 (LPHD) that are needed for public health activities and research.
The proposed national database would merely contain a second,
anonymized copy of the same fragmented, unlinked, disorganized
data that already exist. Unless encounter-level patient data are shared
with the government in identifiable form — a policy that is far more
problematic169 than the one Rodwin has proposed — it is difficult to
see how a national database would add any value.
167. See 45 C.F.R. § 164.514(b)(2)(i)(R), 164.514(c)(2) (2010) (stating that “deidentification” of data under the HIPAA Privacy Rule requires removal of codes, but making an exception for codes that comply with the standard set in section 164.514(c), which
forbids disclosure of the “mechanism for re-identification” (i.e., the code key)); see also
OHRP Guidance, supra note 10 (noting that if code keys are shared with investigators, the
study will be considered human-subject research that requires consent under the Common
Rule).
168. See Rodwin, supra note 23, at 587.
169. See IOM, PRIVACY REPORT, supra note 3, at 82 (reporting results of multiple surveys that found “[p]atients were much more comfortable with the use of anonymized data
(e.g., where obvious identifiers have been removed) than fully identifiable data for research”).
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C. Consent Bias and the Need for Nonconsensual Access to Patients’
Health Data
The proposal by Hall and Schulman solves the data-linkage problem by relying on consensual ordering.170 The patient could authorize
a trusted intermediary to obtain identifiable encounter-level data,
which then could be linked to create the patient’s LHR. The resulting
LHR would be useful for purposes of the patient’s own care.171 It is
not clear, however, that this proposal could generate data resources
for research and public health activities. The problem relates to the
consensual ordering inherent in Hall and Schulman’s scheme of patient-controlled health records. The Hall and Schulman proposal allows the trusted intermediary to use a patient’s LHRs to form LPHD
and to license the LPHD to third-party users — but only on terms controlled by the patient.172
Multiple empirical studies have documented that people who are
willing to consent to letting their data be used in research differ medically from the population at large.173 The underlying reasons are not
well understood, but the impact is clear: conditioning the creation of
LPHD on patient consent produces datasets that may be unreflective
of the general population, thus biasing study results. Similar problems
also exist outside the biomedical context. Burstein notes that information security researchers, when studying threats to our nation’s
critical information infrastructures, need access to realistic data about
people’s Internet usage patterns and electronic communications.174
Internet service providers that possess this information can share it
with researchers, but only if the affected Internet users consent.175
People willing to consent to research with their private information —
potentially including the content of their e-mails — may not provide a
170. See Hall & Schulman, supra note 27, at 1284 (calling for “[p]atient-controlled
health records”).
171. See discussion supra Part III.A.
172. Hall, supra note 23, at 660–61.
173. See generally Brian Buckley et al., Selection Bias Resulting from the Requirement
for Prior Consent in Observational Research: A Community Cohort of People with Ischaemic Heart Disease, 93 HEART 1116 (2007); Casarett et al., supra note 9, at 593–94;
IOM, PRIVACY REPORT, supra note 3, at 209–14 (surveying studies of consent and selection
bias); Khaled El Emam et al., A Globally Optimal k-Anonymity Method for the Deidentification of Health Data, 16 J. AM. MED. INFO. ASS’N. 670, 670 (2009); Steven J. Jacobsen et al., Potential Effect of Authorization Bias on Medical Record Research, 74 MAYO
CLINIC PROC. 330 (1999); Jack V. Tu et al., Impracticability of Informed Consent in the
Registry of the Canadian Stroke Network, 350 NEW ENG. J. MED. 1414 (2004); Steven H.
Woolf et al., Selection Bias from Requiring Patients to Give Consent to Examine Data for
Health Services Research, 9 ARCHIVES FAM. MED. 1111 (2000).
174. Aaron J. Burstein, Amending the ECPA to Enable a Culture of Cybersecurity Research, 22 HARV. J.L. & TECH 167, 170–71, 184–94 (2008).
175. Id. at 185–86 (citing the Omnibus Crime Control and Safe Streets Act of 1968 and
the Electronic Communications Privacy Act of 1986).
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representative sample of all Internet users and likely would not include the cyberterrorists that researchers were hoping to study.
Because of consent bias, Hall and Schulman’s patient-controlled
I-EMRs can generate individual patients’ LHRs but cannot produce
the high-quality, unbiased LPHD that researchers and public health
officials need in order to draw scientifically valid conclusions. The
Hall and Schulman proposal envisions that licensing fees paid by
third-party data users would help finance the informational infrastructure for compiling patients’ LHRs.176 Given the low quality of LPHD
a patient-controlled system can generate, demand from research and
public health users may be limited, and licensing fees may not be a
reliable source of funding for the system.177
Consent bias is a potential problem under any scheme of consensual ordering, and this is true whether it is an opt-in or opt-out consent
scheme. An opt-in approach allows data to be used only if the patient
affirmatively consents.178 Common Rule consents and HIPAA privacy
authorizations exemplify an opt-in approach.179 An opt-out approach
presumes patients’ data can be used, unless the patients take active
steps to exclude their data from use.180 Both schemes let patients exercise control over uses of their data, although the level of effort involved in keeping one’s data from being used differs in the two
schemes. Whenever patients can control uses of their data, there is a
risk that those who exercise control may differ from those who do not,
causing the resulting data set to be unrepresentative of the population
as a whole. A scheme of nonconsensual ordering avoids this problem
because patients cannot self-select for inclusion or exclusion from the
data set.
Rodwin’s analysis excels in its exposition of supply-side factors
that call for nonconsensual ordering of access to data for research and
176. Hall & Schulman, supra note 27, at 1283 (suggesting that patients could authorize
intermediaries to sell their data for use in marketing and research to permitted users, with
proceeds helping to “recoup the considerable expenses of compilation” of the data and
possibly providing some flow of funds back to the patient); see Hall, supra note 23, at 646
(“[P]ropertizing medical information could stimulate increased flow of medical information
into more useful forms by giving stakeholders rights that they can license or sell.”).
177. Hall and Schulman never expressly claimed that their proposed scheme would produce data suited to research and public health uses; they may have envisioned I-EMRs primarily as a tool to improve clinical care. See Hall, supra note 23, at 650 (suggesting that
health insurers might be a source to help cover the costs of generating patient’s interconnected EMRs — a notion that seems to presume I-EMRs would be used in clinical care
rather than in research and public health uses).
178. Mark A. Rothstein, Health Privacy in the Electronic Age, 28 J. LEGAL MED. 487,
490–91 (2007).
179. See 45 C.F.R. § 46.116 (2010) (describing Common Rule consent requirements); id.
§ 164.508 (describing HIPAA authorization requirements).
180. See, e.g., Michael Birnhack & Niva Elkin-Koren, Does Law Matter Online? Empirical Evidence on Privacy Law Compliance, 17 MICH. TELECOMM. & TECH. L. REV. 337, 339
(2011), available at http://www.mttlr.org/volseventeen/birnhack_elkin-korens.pdf.
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public health applications.181 Hall and Rodwin both acknowledge that
diffusion of control among multiple data holders can give rise to a
tragedy of the anticommons.182 Rodwin explores an additional tragedy
of the anticommons that arises when control over data is diffused at
the level of individual patients.183 Likening the problem of assembling
“comprehensive patient databases” to the problem of assembling contiguous parcels of land for real estate development, he explores strategic barriers that make consensual access to data unworkable.184
Rodwin frames his discussion as a comparison of private and
public ownership. This framing obscures an essential feature of his
proposal: it is a scheme of nonconsensual access to patients’ data,
insofar as it requires compulsory reporting of patients’ data to the
government.185 The flaw in Rodwin’s analysis is that it conflates nonconsensual access and governmental ownership. He states that “treating patient data as private property precludes forming comprehensive
databases required for many of its most important public health and
safety uses.”186 This statement is true only if property rights are modeled as conferring property-rule protection (pure consensual ordering).
It discounts the possibility that the needed public access to privately
owned data could be obtained nonconsensually through exercises of
the police or eminent domain powers.187 As Bell has remarked in discussing takings that transfer property into public ownership, such actions are “warranted only where two issues are resolved in favor of
the government: (1) the government is the preferred owner for reasons
of justice or efficiency, and (2) coercion is the preferred transfer
mechanism.”188 The need for nonconsensual access does not necessarily imply a need for governmental ownership.
There are various reasons why the government may not be the
most efficient data owner. For example, federal agencies such as the
HHS, which would own the data under Rodwin’s proposal,189 are regulated by the Privacy Act,190 which protects the privacy of records
held by federal agencies.191 This is an added layer of regulation on top
of the HIPAA Privacy Rule and the Common Rule. This heightened
181. See Rodwin, supra note 23, at 603–06.
182. Hall, supra note 23, at 647–48; Rodwin, supra note 23, at 606.
183. Rodwin, supra note 23, at 606.
184. Id. at 607; see also Hall, supra note 23, at 647 (invoking the land-assembly analogy
to describe strategic barriers in getting multiple data holders to cooperate to assemble a
patient’s complete longitudinal health record).
185. See Rodwin, supra note 23, at 589.
186. Id.
187. See discussion supra Part II.A.
188. Bell, supra note 59, at 534.
189. See Rodwin, supra note 28, at 86; Rodwin, supra note 23, at 615.
190. 5 U.S.C.A. § 552(a) (West 2006 & Supp. 2011); see also Rosati, supra note 89, at 5.
191. IOM, PRIVACY REPORT, supra note 3, at 89.
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regulatory burden, along with other potential disadvantages of public
ownership, would need to be carefully weighed, even if one is prepared to accept that HHS has the resources to construct and operate a
mega-database containing duplicate copies of all of the health data in
the United States. It is thus unclear whether public data ownership is a
good idea. On the other hand, there is a strong case for nonconsensual
access to data for at least some research and public health applications — specifically, those that require unbiased LPHD. Because of
the patient-level anticommons problem Rodwin explored192 and concerns about consent bias, consensual approaches cannot reliably produce unbiased LPHD.
D. The Role of Infrastructure and Demand-Side Factors
Statements such as “[w]hoever owns patient data will determine
whether its benefits can be tapped”193 overstate the importance of controlling one raw material input to a complex, multistage production
process. This statement is true in the same way that the statement
“whoever owns iron ore will determine the fate of the shipbuilding
industry” is true. Certainly, iron ore is a critical input to building a
ship, but it is just one of many factors that influence the development
of facilities that turn iron ore into a valuable asset — steel — and the
steel into ships. In the same way, raw health data are just one of many
inputs for creating useful data resources. This Part explains the importance of other critical inputs — specifically, human and infrastructure services.
There are multiple system architectures that can convert encounter-level patient data into valuable data resources for research and
public health.194 Hall’s proposal does not embrace any particular system architecture for implementing I-EMRs. He merely states that
“[t]he primary barriers are not technological”195 and turns to analysis
of the perceived legal barriers. Rodwin’s analysis implicitly assumes
that a centralized database is necessary in order to assemble encounter-level patient data into LHRs and LPHD.196 His preference for public ownership may have been influenced by the assumption — which
192. See supra notes 183, 185, and accompanying text.
193. Rodwin, supra note 23, at 587.
194. See HEALTHCARE INFO. AND MGMT. SYS. SOC’Y, A HIMSS GUIDE TO
PARTICIPATING IN A HEALTH INFORMATION EXCHANGE 15–20 (2009), available at
http://www.himss.org/content/files/HIE/HIE_GuideWhitePaper.pdf (discussing an array of
possible architectures, including centralized, decentralized (federated), and hybrid models);
Carol C. Diamond, Farzad Mostashari & Clay Shirky, Collecting and Sharing Data For
Population Health: A New Paradigm, 28 HEALTH AFFAIRS 454, 456 (2009).
195. Hall, supra note 23, at 636.
196. Rodwin, supra note 23, at 595 (taking the position that “tapping the real potential
for patient data for secondary uses requires that it be aggregated into a national database”).
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is erroneous — that public access to, and use of, data requires actual
possession of the data in a centralized database.
It is true that in the past informational research typically was performed by gathering data into one large, central database where the
data analysis was performed.197 The modern trend is to use distributed
data networks instead.198 Centralized databases worked satisfactorily
in the days — not so long ago — when a “large scale” observational
study might have involved mere tens to hundreds of thousands of records. Today, however, large-scale studies may use records of tens to
hundreds of millions of persons.199 For example, the Food and Drug
Administration Amendments Act of 2007 (“FDAAA”)200 calls for
pharmacoepidemiological201 studies of postmarket drug safety that
will employ health data for one hundred million persons.202 FDA is
meeting this mandate by developing the Sentinel system,203 and its
pilot Mini-Sentinel system204 already includes data for sixty million
persons.205 Multimillion-person pharmacoepidemiological networks
also are being developed in Canada,206 the European Union,207 and
197. Diamond et al., supra note 194, at 456.
198. Richard Platt et al., The New Sentinel Network — Improving the Evidence of Medical-Product Safety, 361 NEW ENG. J. MED. 645, 645–47 (2009); see also Diamond et al.,
supra note 194, at 460.
199. See Evans, supra note 103, at 73–74 (describing several multimillion-person pharmacoepidemiological data networks now under development).
200. Pub. L. No. 110-85, 121 Stat. 823 (2007) (codified as amended in scattered sections
of 21 U.S.C.).
201. See
Brian
L.
Strom,
What
is
Pharmacoepidemiology?,
in
PHARMACOEPIDEMIOLOGY, supra note 9, at 3, 3 (defining pharmacoepidemiology as “the
study of the use of and the effects of drugs in large numbers of people”).
202. 21 U.S.C.A. § 355(k)(3)(B)(ii) (West 2006 & Supp. 2011) (setting targets of twentyfive million persons by July 2010 and 100 million by July 2012); see also id. § 355(k)(3)(C)
(describing the new “postmarket risk identification and analysis system”).
203. U.S. FOOD & DRUG ADMIN., THE SENTINEL INITIATIVE (2008), available at
http://www.fda.gov/downloads/Safety/FDAsSentinelInitiative/UCM124701.pdf (discussing
the goals and structure of the Sentinel data network); see also FDA’s Sentinel Initiative,
U.S. FOOD & DRUG ADMIN., http://www.fda.gov/Safety/FDAsSentinelInitiative/default.htm
(last modified Oct. 5, 2011) (providing information about the current status of Sentinel
System development).
204. Press Release, U.S. Food & Drug Admin., FDA Awards Contract to Harvard Pilgrim to Develop Pilot for Safety Monitoring System (Jan. 8, 2010),
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm196968.htm.
205. Rachel E. Behrman et al., Developing the Sentinel System — A National Resource
for Evidence Development, 364 NEW ENG. J. MED. 498, 498 (2011).
206. See In Brief: The Drug Safety and Effectiveness Network (DSEN), CANADA INSTS.
OF HEALTH RES., http://www.cihr-irsc.gc.ca/e/39389.html (last modified June 29, 2011)
(describing Canada’s DSEN network); Medicines that Work for Canadians: Business Plan
for a Drug Effectiveness and Safety Network, HEALTH CANADA (2007), http://www.hcsc.gc.ca/hcs-sss/alt_formats/hpb-dgps/pdf/pubs/pharma/2007-med-work_eff/2007-medwork-eff-eng-final.pdf (same).
207. See Press Release, European Medicines Agency, EMEA-Coordinated PROTECT
Project Has Been Accepted for Funding by the Innovative Medicines Initiative Joint Undertaking
(Apr.
30,
2009),
http://www.ema.europa.eu/ema/index.jsp?curl=pages/
news_and_events/news/2009/11/news_detail_000096.jsp&jsenabled=true (describing the
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Japan.208 These systems have not required any clarification of data
ownership and they did not require creation of centralized databases.209 They rely on distributed network architectures.210
In a distributed network, an individual’s health information is not
moved to a central database for storage and analysis; rather, it continues to be stored at its original location (for example, in an insurer’s or
healthcare provider’s database).211 The participating data holders are
linked together virtually.212 Under one design, parties wishing to use
the data send queries to the data holders.213 Suppose, for example, that
an investigator wishes to study whether taking statins may be associated with rhabdomyolysis, a muscle-wasting condition. The investigator would send queries to the various data holders (for example,
“Please locate records for any person in your data system who (1) has
ever taken statins, or (2) has ever suffered from rhabdomyolysis.”).
Records for such patients could be conveyed in identifiable form to a
network coordinating center (a trusted intermediary) that would perform longitudinal linkage of data received from the various data holders. This linkage would make it possible to identify patients who both
took statins and suffered rhabdomyolysis, even if the records of these
two occurrences are scattered across multiple data holders. The trusted intermediary would use the linked data to compile lists of patients
who took statins with and without subsequently developing rhabdomyolysis. These lists then could be de-identified and conveyed to the
investigator for use in the study.
PROTECT network); Implementation of the Action Plan to Further Progress the European
Risk Management Strategy: Rolling Two-Year Work Programme (2008–2009), EUROPEAN
MEDICINES AGENCY (Dec. 24, 2007), http://www.emea.europa.eu/pdfs/human/phv/
28008907en.pdf (describing the ENCePP data network); EUROPEAN NETWORK OF CENTRES
FOR PHARMACOEPIDEMIOLOGY AND PHARMACOVIGILANCE (“ENCePP”), http://encepp.eu
(last modified Sept. 30, 2011); EU-ADR, http://www.alert-project.org/ (last visited Oct. 10,
2011) (describing the European Union adverse drug reactions data network).
208. Kaoru Misawa, Dir., Office of Safety, Pharm. & Med. Devices Agency (“PMDA”),
Address at the 9th Kitasato University-Harvard School of Public Health Symposium: Sentinel Initiative in Japan: Utilization of Electronic Health Information in Pharmacovigilance 7–
14
(Sept.
11–12,
2009),
http://www.pharm.kitasato-u.ac.jp/biostatis/
khsympo200909/doc/misawa.pdf.
209. See generally Behrman et al., supra note 205 (discussing development of the Sentinel System). The Sentinel System has been implemented within the framework of existing
state law without changes to data ownership arrangements. See Richard Platt et al., supra
note 198, at 645–46 (describing the Sentinel System’s distributed architecture); supra notes
206, 207 (briefly describing the architectures of related systems in Canada and Europe).
210. See supra note 209.
211. Evans, supra note 103, at 76.
212. Id. at 75–78 (discussing distributed architectures).
213. Id. at 77 fig.2 (showing a distributed network query structure that provides for longitudinal linkage of data across participating data environments via a trusted intermediary).
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Distributed architecture offers a number of advantages over central databases.214 It avoids the need to invest in duplicative storage
capacity because data reside with the original data holders and are not
redundantly stored at a central location. It also offers advantages in
privacy and data security because the data continue to reside behind
the privacy firewalls of the original data holders, with movements of
data minimized to what is necessary to respond to specific queries (as
opposed to moving all the data to a central repository in anticipation
of unspecified future uses).215 Perhaps the most important advantage,
in terms of data quality, is that distributed networks allow the encounter-level data to be interpreted and processed by the data holders’ own
personnel, who regularly work with the data and are familiar with its
quirks.216 Data holders do not all use standardized record formats.217
Different healthcare providers and insurers describe the same medical
condition in different ways, just as law professors use different terminology to refer to similar concepts (for example, LHR, I-EMR, complete patient record, and longitudinal patient data). Answering a
simple question, such as whether a patient actually had rhabdomyolysis, requires familiarity with how the particular data system records
data. The President’s Council of Advisors on Science and Technology
(“P-CAST”) is pessimistic that a standard record format will ever
emerge: “[A]ny attempt to create a national health IT ecosystem based
on standardized record formats is doomed to failure . . . . With so
many vested interests behind each historical system of recording
health data, achieving a natural consolidation around one record format . . . would be difficult, if not impossible.”218 The notion that a
national database operator could make sense of raw, encounter-level
patient data reported in disparate formats is fanciful.
In a distributed data network, data holders are not just suppliers of
data; they also act as service providers.219 These services may include,
for example, searching the data holders’ records to locate data relevant to the particular query, retrieving data, converting data to a
214. See Diamond et al., supra note 194, at 459; Platt et al., supra note 198, at 645 (discussing these advantages).
215. See supra note 214; Judith Racoosin et al., Symposium at the 27th International
Conference on Pharmacoepidemiology, FDA’s Mini-Sentinel Program to Evaluate the Safety of Marketed Medical Products: Progress and Direction 27–28 (Aug. 17, 2011),
http://www.mini-sentinel.org/work_products/Publications/Mini-Sentinel_Progress-andDirection.pdf (listing reasons for preferring a distributed architecture).
216. See Platt, supra note 198, at 646; Racoosin et al., supra note 215, at 28.
217. PRESIDENT’S COUNCIL OF ADVISORS ON SCI. AND TECH., EXEC. OFFICE OF THE
PRESIDENT, REPORT TO THE PRESIDENT: REALIZING THE FULL POTENTIAL OF HEALTH
INFORMATION TECHNOLOGY TO IMPROVE HEALTHCARE FOR AMERICANS: THE PATH
FORWARD 39 (2010) [hereinafter P-CAST REPORT].
218. Id.
219. See Evans, supra note 103, at 86–90 (discussing the types of infrastructure that
FDAAA envisions will be necessary to support operations of FDA’s Sentinel System).
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common format that will allow data from multiple data holders to be
combined, and preparing the search results for transmittal to the user.220 The term “data provisioning” is sometimes used to refer to these
types of services.221 Encounter-level patient data are transformed into
valuable information resources (LHRs and LPHD) through the addition of services.222
This fact has important implications. It no longer can be said that
“[w]hoever owns patient data will determine whether its benefits can
be tapped.”223 Tapping the benefits requires both data and services,
and control over data is unavailing without the services. Some argue
that health data resources are nonrivalrous.224 It is probably fair to say
that encounter-level patient data are nonrivalrous because many people can use raw data without exhausting the supply. However, these
data have few uses except in the patient’s own care, so it is not clear
why large numbers of people would want to use them. LHRs and
LPHD, which do have many potential uses, are subject to potential
supply constraints: there is a finite supply of the services needed to
convert raw data into LHRs and LPHD. Data holders do not have unlimited personnel and data processing resources to respond to queries.
Preparing LPHD to respond to one query may diminish the availability of LPHD for another query. The most valuable information resources for clinical, research, and public health applications are LHRs
and LPHD, and these can only be supplied by a constrained infra-
220. Houtan Aghili, Senior Technical Staff Member, Presentation to Maryland Task
Force: IBM Healthcare & Life Sciences, IBM NHIN-Enabled Health Information Exchange
(“NHIE”) 3 (July 9, 2007), http://mhcc.maryland.gov/electronichealth/presentations/
ibm2_0707.pdf (listing, in a presentation about development of a statewide health information exchange, various “data services” that a health information network needs to enable
as “core services,” including “secure data delivery;” “data look-up, retrieval, and location
registries;” and “data anonymization”).
221. See, e.g., id. (listing among the core services that a networked health information
exchange provides, “[s]upport for secondary use of clinical data including data provisioning”); Paul J. Ambrose, Arun Rai & Arkalgud Ramaprasad, Internet Usage for Information
Provisioning: Theoretical Construct Development and Empirical Validation in the Clinical
Decision-Making Context, 53 IEEE TRANSACTIONS ON ENGINEERING MGMT. 112 (2006),
available at http://ieeexplore.ieee.org/arnumber=1580898 (providing another example of the
term “information provisioning” to refer to making information available for use by decision makers in the healthcare context); 29 Information Provisioning Concepts, ORACLE
STREAMS
CONCEPTS
AND
ADMINISTRATION
11G
RELEASE
1
(11.1),
http://download.oracle.com/docs/cd/B28359_01/server.111/b28321/strms_ipro.htm
#BHCIEBGD (last visited Dec. 21, 2011) (“Information provisioning makes information
available when and where it is needed.”).
222. See Aghili, supra note 220, at 3 (providing examples of core services provided by a
health information network that is capable of accessing and manipulating raw health data to
create useful data resources for secondary purposes such as research and public health applications).
223. Rodwin, supra note 23, at 587.
224. See Hall, supra note 23, at 661 (“Information by its nature is nonrivalrous . . . .”).
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structure. These resources are only partially nonrivalrous — that is,
they are nonrivalrous only within capacity constraints.225
The fact that the necessary services are costly and in finite supply
has ramifications for system design. A key design decision is whether
a system needs to be able to produce LHRs and LPHD ahead of demand, as opposed to satisfying demand after it arises. The answer depends on whether the planned applications — clinical care, research,
and public health studies — are latency-sensitive.226 The concept of
latency (colloquially understood as “delay”) has been a concern in
discussions of Internet policy.227 Some Internet applications are latency-sensitive — that is, small delays in delivery of information will
disrupt their functionality — while others are latency-insensitive.
“Consider that it doesn’t matter whether an email arrives now or a few
milliseconds later. But it certainly matters for applications that want to
carry voice or video.”228 Clinical uses of LHRs are potentially latency-sensitive: clinicians treating a patient in the emergency department
cannot afford to wait for compilation of the patient’s LHR. On the
other hand, the use of LHRs in scheduled clinical care may not be
latency-sensitive: when a patient makes a doctor’s appointment, a
request could be made to compile the patient’s LHR for delivery on
the date of the scheduled appointment. Many research and public
health uses of LPHD are latency-insensitive: it does not destroy the
validity of a study if it takes a few days or weeks to supply the necessary data resources.
Because of these differences, the optimal infrastructure to supply
data resources for one use may not be optimal for supplying other
uses. For latency-sensitive applications, data resources need to be
compiled ahead of the demand for them. Patient-controlled I-EMRs,
such as those proposed by Hall and Schulman, are thus a potentially
useful tool for clinical care. Patients can request compilation of their
LHRs in advance so that they will be available in emergencies, and
then patients can periodically update their LHRs. For latencyinsensitive applications, such as most research and public health studies, compilation can be deferred until there is an identified demand.
This distinction affects the required system design and can drastically
affect system costs when, as here, compiling the information resources requires inputs of scarce, costly services. There would be little
advantage — and an enormous cost disadvantage — in developing a
centralized, national database containing every person’s compiled
225. See Frischmann, supra note 75, at 951 (defining partially nonrivalrous resources).
226. See Tim Wu, Network Neutrality, Broadband Discrimination, 2 J. ON TELECOMM. &
HIGH TECH. L. 141, 148 (2003) (defining and discussing the impact of latency on Internet
applications).
227. Id.; see also Frischmann, supra note 75, at 1008–10.
228. Wu, supra note 226, at 148.
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LHR. Compiling information resources (LHRs and LPHD) in anticipation of all conceivable research and public health uses may be as illadvised as it would be to manufacture false teeth for every American
in anticipation that they may eventually need them.
A distributed architecture can respond to queries as they occur,
and this attribute offers important economic advantages in latencyinsensitive research and public health applications. In the future, the
development of new infrastructure may reduce the latency itself — in
other words, reduce the delays associated with locating relevant patient data and converting them to a consistent format for assembly into
LHRs and other useful data resources.229 At present, these services are
labor-intensive. The recent P-CAST report calls for creation of a universal exchange language and infrastructure to facilitate assembly and
sharing of patient data across data holders.230 Data holders would continue to operate a variety of systems, including the old legacy systems
in operation today and new recordkeeping systems and formats.231
The “syntax for such a universal exchange language will be some kind
of extensible markup language (an XML variant, for example) capable of exchanging data from an unspecified number of (not necessarily harmonized) semantic realms.”232 Individual data elements — such
as a person’s X-ray or clinical observations about the patient — would
be annotated with metadata tags containing enough identifying information to let the patient’s records be located, recording information
about the patient’s privacy preferences, and explaining the provenance
of the data (such as which healthcare providers were involved and
what type of test or equipment they used).233 A national infrastructure
would support searches and deliver results appropriately compiled and
processed to protect privacy. Locating all of a patient’s data, wherever
stored, would work similarly to the way an Internet search engine
works today.234 Until such a solution is implemented, LHRs and
229. See P-CAST REPORT, supra note 217, at 11 (noting that the present “lack of data
exchange also means that researchers and public health agencies have limited access to data
that could be used to improve health systems and advance biomedical research”); id. at 63
(noting that “[t]oday’s clinical research studies are not carried out in real time” and may be
“[o]ut of date before they are even finished”); id. at 54 (calling for creation of a distributed
network that “links healthcare providers, patients, labs, researchers, and other stakeholders
and enables qualified users to query distributed data stored by partners in the network”); id.
at 64 (noting that such a system offers the “[p]otential for [r]eal-[t]ime, [r]eal-[w]orld, and
[c]omprehensive [d]ata” and discussing various public health and research questions that
could be addressed “using large datasets gathered through ongoing medical care, particularly if the data were available in near real time”).
230. Id. at 4.
231. Id. at 41.
232. Id.
233. Id.
234. See id. at 4 (noting that the Office of the National Coordinator for Health Information Technology proposed using the clinical document architecture standard, an estab-
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LPHD will continue to require labor-intensive services. The hope,
eventually, is to replace some of the human services with more capital-intensive infrastructure services.
Installing new infrastructure requires money. P-CAST acknowledges that federal leadership will be required; “market forces are unlikely to generate appropriate incentives for the necessary
coordination to occur spontaneously.”235 This view is far more pessimistic than the view, expressed by Hall and Schulman, that altering
patient’s entitlements to their health data “will help stimulate market
development of interconnected EMRs.”236 The problem with clarifying ownership of health data is that it is a supply-side solution — and
this remains true whether ownership is clarified in favor of patients
(as in Hall and Schulman’s proposal) or the public (as in Rodwin’s
proposal). In contrast, health information infrastructure — like any
infrastructure — exhibits problems both on the supply and demand
sides.237 An example is the P-CAST proposal just described. The proposal could reduce delays in supplying LHRs and LPHD, but the
market may not value the incremental speed because many health data
applications are not latency-sensitive. Researchers who can afford to
wait for a good data set may not be willing to pay more for a good
data set delivered sooner. That is a demand-side issue.
There are other demand-side issues. The price users would be
willing to pay for health data resources may not reflect the true value
of those resources because so many uses of health data (such as research and public health activities) themselves produce public and
nonmarket goods.238 In this situation, data users are unable to appropriate the full value their activities create; thus, they cannot afford to
pay a price that reflects the data’s true value.239 Frischmann has noted
that market failure for infrastructure is more complex than supply-side
analysis suggests.240 “For both traditional and nontraditional infrastructure resources, analysts emphasize supply-side issues . . . and
lished and highly developed technology that is the basis of web search engines, to support
indexing and retrieval of metadata-tagged health data across large numbers of geographically diverse locations); id. at 42 (indicating that the data-element access services in P-CAST’s
proposed system “would act much like today’s web search engines” but with additional
privacy protections).
235. Id. at 4.
236. Hall, supra note 23, at 638.
237. See Frischmann, supra note 75, at 930 (arguing that market failures affecting infrastructure industries are complex and include demand-side issues as well as supply-side
issues).
238. Id. at 966–67 (defining and comparing public and nonmarket goods).
239. Id. at 968 (“Infrastructure users that produce public goods and nonmarket goods suffer valuation problems because they generally do not fully measure or appropriate the (potential) benefits of the outputs they produce and consequently do not accurately represent
actual social demand for the infrastructure resource.”).
240. Id. at 930.
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assume that the market mechanism will best generate and process demand information.”241 Data propertization proposals assume that if
encounter-level patient data were simply assigned to the right owner,
the market would be able to figure out the right price to pay for useful
data resources such as LHRs and LPHD, and this price would cover
the cost of necessary infrastructure and services to create those resources. This is not a safe assumption.
E. Why Data Propertization Proposals Fail
To summarize, encounter-level patient data are an input that can
be transformed into high-valued data resources — LHRs and
LPHD — for use in clinical care, research, and public health activities. Making these data resources also requires inputs of human and
infrastructure services — that is, data provisioning services. In theory,
it is possible to produce LHRs for use in clinical care under a patientcontrolled system. Such a system would subject all transfers of encounter-level patient data to consensual ordering, which would require
permission of the patients whose data are involved. There are major
limitations to such a system, however. Because of consent bias, the
system cannot supply unbiased LPHD for use in research and public
health projects. Research and public health users thus cannot be
counted on to cross-subsidize the costs of developing patientcontrolled LHRs. Unless the costs of developing patient-controlled
LHRs are justified by the value they create in clinical care, a patientcontrolled system may not be financially viable. Creating high-valued
data resources for research and public health requires a framework of
nonconsensual access to patients’ raw health data. The HIPAA Privacy Rule and the Common Rule both allow nonconsensual access to
patients’ data for public health and research uses.242 If patients owned
their encounter-level data, nonconsensual access for these uses still
would be possible through exercise of the police and eminent domain
powers.
The nub of the problem with data propertization is that it is a supply-side solution that neglects important infrastructural and demandside issues. Access to raw patient data is necessary, but not sufficient,
to ensure an adequate supply of useful data resources. Data provisioning services also are required. The prospective provision of services is
inherently consensual in our system of law. The state’s police and
eminent domain powers only allow nonconsensual transfers of property; there is no similar mechanism to compel nonconsensual provision
241. Id.
242. See discussion supra Part II.B.
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of services.243 The government generally obtains services consensually, by entering into contracts,244 requiring services in return for a
grant,245 or conditioning participation in a desirable program (such as
asking hospitals to report data as a condition of Medicare eligibility).246 The HIPAA Privacy Rule and the Common Rule have no provisions requiring nonconsensual access to data provisioning services;
waivers only permit data holders to disclose data but do not require
them to do so.247 This is fair: data holders have only limited capacity
to supply services and need discretion to refuse. Nonconsensual access to data is possible whether under a property regime or under the
regulatory regime provided by the Common Rule and HIPAA Privacy
Rule. Nonconsensual access to services is not possible under either
regime. Access to infrastructure services, rather than the unresolved
status of data ownership, is thus the key impediment to data availability.
243. See Susan W. Brenner with Leo L. Clarke, Civilians in Cyberwarfare: Conscripts,
43 VAND. J. TRANSNAT’L L. 1011, 1056–57 (2010) (noting, in a discussion of whether the
government can require civilian information technology professionals to perform services
aimed at protecting against cyberterrorism, that there has been only one instance — during
the Revolutionary War — when Congress compelled civilians to provide services other than
in the context of conscription for military service).
244. See Steven J. Kelman, Contracting, in THE TOOLS OF GOVERNMENT 282, 283–85
(Lester M. Salamon ed., 2002) (discussing features of contracts through which the government procures products or services for its use); see also Ruth Hoogland DeHoog & Lester
M. Salamon, Purchase-of-Service Contracting, in THE TOOLS OF GOVERNMENT supra, 316,
320 (describing contracts in which the government procures services for delivery to third
parties such as beneficiaries of welfare programs).
245. See David R. Beam & Timothy J. Conlan, Grants, in THE TOOLS OF GOVERNMENT,
supra note 244, at 340, 341 (discussing the government’s use of grants to stimulate performance of services).
246. See, e.g., 42 C.F.R. § 482.30(c) (2010) (requiring hospitals that participate in the
Medicare program to conduct utilization reviews of care provided to Medicare patients); id.
§ 482.42 (requiring hospitals that participate in the Medicare program to implement infection control programs); id. § 482.13(g) (requiring hospitals that participate in the Medicare
program to compile statistics on deaths that occur while patients are under physical restraints and to report these statistics to the Centers for Medicare and Medicaid Services).
247. Id. § 164.512(i) (providing, in the HIPAA waiver provision, that uses and disclosures pursuant to a waiver are “permitted” — i.e., disclosures are allowed but not required);
id. § 46.116(d) (couching the Common Rule’s waiver provision in similarly permissive
language: “An IRB may approve . . . .”). The IRB of a research institution that wishes to
receive data from a data holder can approve a waiver authorizing release of the data. See
Standards for Privacy of Individually Identifiable Health Information, 65 Fed. Reg. 82,695
(Dec. 28, 2000) (rejecting, in the preamble to the HIPAA Privacy Rule, suggestions that
HHS should require IRBs that approve waivers to be independent of the entity conducting
the research). Under section 164.512(i), recipient-approved waivers permit the data holder
to disclose data but do not require it, so the recipient has no way to force the provision of
needed data and services.
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IV. THE HITECH ACT’S STRATEGY FOR PROMOTING
INFRASTRUCTURE DEVELOPMENT
This Part challenges claims248 that the HITECH Act, which Congress passed as part of the 2009 economic stimulus legislation,249 did
little to promote interconnection of health information systems. It is
true that the HITECH Act does not expressly require interconnection
or data sharing. However, it does something arguably more important:
it clarifies the price of data provisioning services, and it authorizes
data holders to conduct commercial transactions for sale of those services.250 In doing so, it lays groundwork for a commercial market in
data provisioning services and provides a mechanism to finance private-sector development of health information infrastructure. The
HITECH Act accepts that access to data provisioning services is inherently consensual. It authorizes a pricing structure that, if properly
implemented, will create incentives for data holders and other potential service providers to “come to the market” by supplying data provisioning services within existing capacity constraints and by
investing to expand capacity.
A. The Regulated Price of Infrastructure Services
At first glance, the HITECH Act purports to restrict sales of
health data.251 It states a general rule that it is unlawful for HIPAAcovered entities and their business associates to exchange a person’s
protected health information for direct or indirect remuneration — in
other words, to sell data — unless the person authorizes the transaction.252 However, this restriction is tempered by a list of exceptions.253
One exception pertains to research: data holders that supply data to
researchers pursuant to a HIPAA waiver254 can charge a price that
“reflects the costs of preparation and transmittal of the data.”255 In
July 2010, the Office for Civil Rights (“OCR”) within the HHS pro248. See, e.g., Hall, supra note 23, at 635 (“[T]he economic stimulus act contains no legal requirement that funded systems actually interconnect to form a consolidated medical
record for each patient . . . .”); Rodwin, supra note 23, at 595 (discussing the goal of “sharing of patient data for research and public uses” and noting that the “HITECH does not
appear to authorize creating regulations that can achieve that goal”).
249. See American Recovery and Reinvestment Act of 2009, Pub. L. No. 111-5, 123 Stat.
115.
250. See discussion infra this Part.
251. 42 U.S.C.A. § 17935(d) (West 2010 & Supp. 2011).
252. Id. § 17935(d)(1).
253. Id. § 17935(d)(2).
254. 45 C.F.R. § 164.512(i) (2010) (allowing an IRB or privacy board to waive HIPAA’s
usual requirement that patients authorize the use of their data in research).
255. 42 U.S.C.A. § 17935(d)(2)(B).
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posed a regulation implementing this provision.256 The proposed regulation tracks the statute closely and would permit the sale of data for
use in research under a HIPAA waiver so long as the entity supplying
the data receives only “a reasonable cost-based fee to cover the cost to
prepare and transmit” the data.257 The individual’s permission is required only if the data supplier wishes to charge a price higher than
this cost-based fee.258
To be clear, these provisions do not “monetiz[e] medical information.”259 The cost-based fee for data preparation and transmittal260
is not a price for data; it is a price for data-provisioning services. Insurers, healthcare providers, and other entities that operate health databases own infrastructure, such as computer systems and software, in
which they have invested to support their regular lines of business.
With the aid of this infrastructure, it is possible to sift through large
volumes of data, select information that meets a researcher’s specifications, and process it for transmission to the researcher. The fee described in the HITECH Act261 is for these sorts of infrastructure
services. Technically speaking, the data are supplied at no charge and
the fee is for services provided in responding to the data request.
The HITECH Act has another exception for public health uses of
data: when supplying data for public health activities, data holders can
charge a fee for data preparation and transmittal, and this fee is not
subject to the cost-based cap.262 It may at first seem wrongheaded for
data holders to charge higher fees when supplying data for public
health uses, which traditionally have been viewed as having a greater
social value than research.263 Yet this policy makes sense if you assume that the data supply is infrastructure-constrained. Under such
256. Modifications to the HIPAA Privacy, Security, and Enforcement Rules Under the
Health Information Technology for Economic and Clinical Health Act, 75 Fed. Reg. 40,868,
40,921 (proposed July 14, 2010) (to be codified at 45 C.F.R. pts. 160, 164) (proposing a
new regulation to be codified at 45 C.F.R. § 164.508(a)(4)(ii)(B), still not finalized as of this
writing).
257. Id.
258. See id. (proposing new regulations to be codified at 45 C.F.R. § 164.508(a)(4)(i),
164.508(a)(4)(ii)(B), still not finalized as of this writing, requiring patient authorization
before data can be disclosed for remuneration, but allowing authorization to be waived
when remuneration is limited to a reasonable, cost-based fee).
259. See Hall, supra note 23, at 651 (noting that “law either prohibits monetizing medical
information, or it does not clearly permit this” and proposing to allow patients to sell rights
to their data).
260. 42 U.S.C.A. § 17935(d)(2)(B) (West 2010 & Supp. 2011).
261. Id.
262. 42 U.S.C. § 17935(d)(2)(A) (2006); see also Modifications to the HIPAA Privacy,
Security, and Enforcement Rules Under the HITECH Act, 75 Fed. Reg. at 40,921 (proposing a new regulation to be codified at 45 C.F.R. § 164.508(a)(4)(ii)(A), still not finalized as
of this writing).
263. See GOSTIN, supra note 33, at 47 (noting the high value traditionally accorded to
public health activities).
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conditions, a higher fee helps support investment in needed systems264
to resolve the constraint, thus promoting wider availability of data for
public health activities. By letting public health users pay more than
researchers, Congress is helping ensure adequate flows of data for
public health purposes. Later, when the United States has completed
installation of its basic health information infrastructure, it may make
sense to cap the fees for public health as well as research uses, and the
HITECH Act envisions this possibility.265
B. Why the HITECH Act’s Approach Offers Promise
In common parlance, “cost-based” means “at cost,” so this new
pricing scheme may not initially sound promising as a way to spur
investment in interconnected data systems. However, the OCR’s “reasonable, cost-based fee”266 for data provisioning needs to be judged in
light of precedents from other infrastructure industries. Health information systems are infrastructure,267 and the HITECH Act’s costbased fee echoes cost-of-service pricing traditionally used in many
other American infrastructure industries such as electric power transmission and telecommunications.268 Historically, many of these industries exhibited natural monopoly characteristics or other structural
problems that made it unwise to let prices be set by market forces.269
264. See CHARLES F. PHILLIPS, JR., THE REGULATION OF PUBLIC UTILITIES 172 (1993)
(noting the necessity of adequate earnings to support development and expansion of infrastructure industries).
265. See 42 U.S.C.A. § 17935(d)(3)(B) (West 2010 & Supp. 2011) (allowing the Secretary of HHS to apply the cost-based cap on data supplied for public health use at a later
time, based on an evaluation of how it would affect the availability of data). OCR is presently evaluating now whether its cost-based fee structure should apply to public health users as
well as to researchers. Modifications to the HIPAA Privacy, Security, and Enforcement
Rules Under the HITECH Act, 75 Fed. Reg. at 40,891.
266. Modifications to the HIPAA Privacy, Security, and Enforcement Rules Under the
HITECH Act, 75 Fed. Reg. at 40,921 (proposing a new regulation to be codified at 45
C.F.R. § 164.508(a)(4)(ii)(B), still not finalized as of this writing).
267. See JOSÉ A. GÓMEZ-IBÁÑEZ, REGULATING INFRASTRUCTURE 4 (2003) (defining infrastructure as “networks that distribute products or services over geographical space”).
268. See Richard A. Posner, Natural Monopoly and its Regulation, 21 STAN. L. REV.
548, 592 (1969) (discussing the traditional utility regulatory process, which sets regulated
prices based on an “allowed cost of service [which] includes an allowance for a ‘fair return’
to [investors] who have provided the capital used to render the regulated service”); see also
PHILLIPS, supra note 264, at 377, 381, 385 (highlighting key cost-of-service pricing principles).
269. See GÓMEZ-IBÁÑEZ, supra note 267, at 4–6 (discussing rationales for infrastructure
regulation); PHILLIPS, supra note 264, at 51–60 (discussing natural monopoly characteristics
and structural issues that may call for price regulation); Hank Intven, Jeremy Oliver & Edgardo Sepulveda, THE WORLD BANK INFORMATION FOR DEVELOPMENT PROGRAM
(INFODEV), TELECOMMUNICATIONS REGULATION HANDBOOK § 1.1.1 box 1-1 (Hank Intven
ed., 2000) (“Where competitive markets do not exist or fail, [a widely accepted regulatory
objective is to] prevent abuses of market power such as excessive pricing and anticompeti-
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These concerns supplied the rationale for imposing cost-based pricing.270 Starting with the Interstate Commerce Act of 1887, which regulated railroads,271 Congress imposed cost-of-service pricing on the
interstate shipping,272 stockyard,273 telephone,274 telegraph,275 trucking,276 electricity,277 natural gas,278 and aviation279 industries.280 Costof-service pricing remained common in U.S. infrastructure regulation
until late in the twentieth century, when it was partially supplanted by
reforms281 that rely more heavily on market pricing of infrastructure
services.282
Why, at a time when cost-of-service pricing is under critique in
other industries, did Congress impose a cost-based fee structure on
data provisioning services? The modern critique of cost-of-service
pricing focuses on its potential to be inefficient and cumbersome to
administer.283 This critique emerged late in the twentieth century,
when the major policy challenge was to optimize utilization of existing infrastructures, as opposed to financing and building new infrastructures.284 Chen notes that traditional cost-of-service infrastructure
regulation may actually be the more efficient approach under economic conditions that existed earlier in the twentieth century.285 At that
time, policymakers’ central challenge was to develop new infrastructures. That is the same challenge policymakers face now with respect
to America’s health information infrastructure — to get it built. In the
tive behavior . . . .”); id. § 5.2.2–5.2.4 (discussing market imperfections common in infrastructure industries such as telecommunications).
270. See PHILLIPS, supra note 264, at 182–83; GÓMEZ-IBÁÑEZ, supra note 267, at 5–6.
271. Interstate Commerce Act of 1887, Pub. L. No. 49-104, ch. 104, 24 Stat. 379, 379
(codified as amended in scattered sections of 49 U.S.C.).
272. Shipping Act of 1916, Pub. L. No. 64-260, ch. 451, 39 Stat. 728, 733–35 (codified
as amended in scattered sections of 46 U.S.C.).
273. Packers and Stockyards Act of 1921, 7 U.S.C. §§ 181–229c (2006).
274. Communications Act of 1934, Pub. L. No. 73-416, ch. 652, 48 Stat. 1064, 1070
(codified as amended in scattered sections of 47 U.S.C.).
275. Id.
276. Motor Carrier Act of 1935, Pub. L. No. 74-255, ch. 498, 49 Stat. 543, 543 (codified
as amended in scattered sections of 49 U.S.C.).
277. Public Utility Act of 1935, Pub. L. No. 74-333, ch. 687, 49 Stat. 803, 839–40 (codified as amended at scattered sections of 16 U.S.C.).
278. Natural Gas Act of 1938, 15 U.S.C. §§ 717–717w (2006).
279. Civil Aeronautics Act of 1938, ch. 601, 52 Stat. 973, 993 (repealed 1958).
280. See Joseph D. Kearney & Thomas W. Merrill, The Great Transformation of Regulated Industries Law, 98 COLUM. L. REV. 1323, 1333–34 (1998) (citing statutes imposing
cost-of-service pricing on several industries).
281. See Jim Chen, The Nature of the Public Utility: Infrastructure, the Market, and the
Law, 98 NW. U. L. REV. 1617, 1618 (2004) (reviewing GÓMEZ-IBÁÑEZ, supra note 267).
282. See Kearney & Merrill, supra note 280, at 1333–40.
283. See Chen, supra note 281, at 1631 (noting that public utility regulation is criticized
as creating problems of “indeterminacy and inefficiency”).
284. Cf. id. at 1620–21 (discussing the changes in infrastructure priorities from the nineteenth to the twentieth centuries).
285. Id. at 1633, 1650.
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HITECH Act, Congress embraced a pricing structure that, during the
past 100 years, has successfully financed private-sector development
of many other major infrastructures in the United States.286
Critical to this success was the role courts played in interpreting
what a “reasonable, cost-based” price must include. More than a century of Supreme Court cases have examined cost-of-service pricing in
many different infrastructure contexts.287 Under these precedents, a
reasonable, cost-based fee for infrastructure services must — in order
to be constitutional — let infrastructure owners recover: (1) their variable and fixed operating costs of providing services, (2) their capital
investment in the infrastructure itself, and (3) a reasonable profit margin.288 The HITECH Act’s cost-based fee structure, if implemented in
accordance with these precedents, would foster creation of a commercial market in the infrastructure services that are needed to convert
encounter-level patient data into valuable data resources for research
and public health. In July 2010, the OCR sought public comments on
how, precisely, it should define the cost-based fee289 and has not, as of
this writing, issued final regulations clarifying what the fee will cover.
However, the OCR presumably must heed past Supreme Court decisions that addressed cost-based pricing in other infrastructure contexts. Should the OCR fail to do so, data holders would have grounds
to challenge the constitutionality of the cost-based fee. The precedents
286. See supra notes 271–280 (listing industries that were built under regulated, cost-ofservice pricing).
287. See Written Statement, Barbara J. Evans, Law Professor, Comments on Proposed
Rule RIN 0991-AB57: Modifications to the HIPAA Privacy, Security, and Enforcement
Rules Under the Health Information Technology for Economic and Clinical Health Act 4-12
(2010), available at http://www.regulations.gov/#!documentDetail;D=HHS-OCR-20100016-0086 (reviewing cases in which the U.S. Supreme Court ruled on the constitutionality
of cost-of-service fee structures in other infrastructure regulatory contexts)
288. Id.; see, e.g., Bluefield Water Works & Imp. Co. v. Pub. Serv. Comm’n, 262 U.S.
679, 690 (1923) (“Rates which are not sufficient to yield a reasonable return on the value of
the property . . . deprive[] the public utility company of its property in violation of the Fourteenth Amendment.”); id. at 692–93 (identifying factors to consider in determining whether
a company’s allowed rate of return is confiscatory); Chicago, Milwaukee & St. Paul Ry. Co.
v. Minnesota, 134 U.S. 418, 458 (1890) (“If the company is deprived of the power of charging reasonable rates for the use of its property . . . it is deprived of the lawful use of its property, and thus, in substance and effect, of the property itself, without due process of
law . . . .”); see also PHILLIPS, supra note 264, at 376–82 (providing a brief history and
discussion of standards the court has enunciated with respect to a fair return on invested
capital); id. at 257–60 (reviewing Supreme Court cases that confirmed the right of utility
companies to recover operating expenses, including an allowance for depreciation of invested capital).
289. Modifications to the HIPAA Privacy, Security, and Enforcement Rules Under the
Health Information Technology for Economic and Clinical Health Act, 75 Fed. Reg. 40,868,
40,891 (July 14, 2010) (to be codified at 45 C.F.R. pts. 160, 164) (seeking public comment
on what should be included in the cost-based fee).
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strongly favor data holders’ claims to receive full recovery of their
operating and capital costs, plus a reasonable profit margin.290
Governmental intervention in markets is justified when barriers — for example, economic or legal — are blocking private-sector
development of necessary infrastructure.291 Various forms of intervention are possible, ranging from industry-specific regulation292 to outright public ownership and operation of infrastructure.293 The United
States has rejected the latter option consistently throughout its history294 and instead has regulated its infrastructure industries, including
regulation of their pricing.295 The HITECH Act’s data sales provisions
can be seen as a traditional American approach to the problem of getting major, new infrastructure developed. Rather than have the government build big databases or otherwise own health information
infrastructure, the HITECH Act presumes the infrastructure will be
developed, owned, and operated by the private sector subject to costbased pricing of infrastructure services.
V. WHAT STILL NEEDS TO BE DONE
The HITECH Act’s pricing provisions may improve the situation,
but all is not well. There remains a widely shared perception that the
HIPAA Privacy Rule and the Common Rule are blocking socially
beneficial uses of data while still under-protecting individual privacy.296 These perceptions persist, this Part argues, not because of a
mere failure to propose answers; instead, the wrong questions are being asked. This Part seeks to reframe the discussion to focus on two
crucial questions that fell by the wayside during the long debate297 —
from 1974 to 2002 — that produced these regulations in their current
form.
290. See supra notes 287–288 and accompanying text (discussing these precedents).
291. See generally PHILLIPS, supra note 264, at 172–73; GÓMEZ-IBÁÑEZ, supra note 267,
at 20–21; Chen, supra note 281, at 1624–28.
292. Chen, supra note 281, at 1628.
293. GÓMEZ-IBÁÑEZ, supra note 267, at 13; Daniela Klingebiel & Jeff Ruster, Why Infrastructure Financing Facilities Often Fall Short of Their Objectives 7 (World Bank Policy
Research, Working Paper No. 2358, 2000).
294. GÓMEZ-IBÁÑEZ, supra note 267, at 2; Chen, supra note 281, at 1633 (citing STEVEN
BREYER, REGULATION AND ITS REFORM 181–83 (1982)) (pointing out that the U.S. is the
only nation that maintained private ownership of its major infrastructure networks, such as
pipelines and power grids, throughout the entire twentieth century).
295. See PHILLIPS, supra note 264, at 171–72 (noting that rate regulation has been an important component in the regulation of public utility infrastructures).
296. See supra notes 3–5.
297. See supra notes 11–13 and accompanying text.
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A. Restoring the Proper Scope of the State’s Police Power to Use
Data to Promote Public Health
The first neglected question is, “What is the scope of the state’s
police power to use private health data to promote public health?”
Regulatory practice under the Common Rule conceives the scope of
the state’s police power more narrowly than it is conceived in other
legal contexts.298 This anomaly can be traced to an original sin during
design of the Common Rule: its framers failed to define public health
actions or delineate when they should be exempt from the Common
Rule’s consent requirements. The National Commission formed under
the National Research Act of 1974299 was instructed to delineate the
boundary between research and medical treatment.300 There was no
similar directive to clarify the boundary between research and public
health actions. This left a gray area in which the state’s power to use
data to protect the public’s health is sometimes made subject to individual consent.
The Belmont Report301 — which set the ethical principles embodied in the Common Rule — defined research as an activity that produces generalizable knowledge.302 Using generalizability to mark the
line between research and treatment worked well; it kept common
“experimental” therapeutic practices, such as the off-label use of
drugs in routine clinical care, from falling under the jurisdiction of the
Common Rule.303 This definition carried through to the Common
Rule’s definition of “human-subject research”304 and HIPAA’s definition of “research.”305 Generalizability has jurisdictional significance
under the Common Rule: it delineates whether an activity is, or is not,
“human-subjects research” that is regulated by the Common Rule (and
thus subject to its informed consent requirements). It does not have
298. See supra notes 66–68 and accompanying text (discussing the state’s ability to confiscate or interfere with property when the state is acting under its police power); Merrill,
supra note 61, at 66 (characterizing legitimate exercises of police power as circumstances in
which the property owner has “no entitlement”).
299. National Research Act of 1974 (National Research Service Award Act of 1974),
Pub. L. No. 93-348, 88 Stat. 342, 348–51 (codified as amended in scattered sections of 42
U.S.C.); see also HEW, 1978 REPORT, supra note 8, at 56,174 (publishing recommendations as required by the National Research Act of 1974).
300. U.S. DEP’T OF HEALTH, EDUC., & WELFARE, OFFICE OF THE SEC’Y, BELMONT
REPORT: ETHICAL PRINCIPLES AND GUIDELINES FOR THE PROTECTION OF HUMAN SUBJECTS
OF RESEARCH, 44 Fed. Reg. 23,192, 23,192 (Apr. 18, 1979) [hereinafter BELMONT REPORT]
(“[T]he [National] Commission was directed to consider . . . the boundaries between biomedical and behavioral research and the accepted and routine practice of medicine . . . .”).
301. Id.
302. Id. at 23,193.
303. Id.
304. See 45 C.F.R. § 46.102(d), 46.102(f) (2010) (defining “research” and “human subject”).
305. Id. § 164.501.
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similar significance under HIPAA, which creates status-based jurisdiction that depends on attributes of the data holder.306
The problem under the Common Rule is that generalizability of
results does not provide a good bright-line rule for determining
whether public health actions should or should not require consent.
For example, vaccinating people to control a smallpox epidemic is
permissible even without their consent;307 vaccinating people to see
which of two vaccines works better is research that obviously should
require consent. Nonconsensual vaccination is justified in the first
case not because it fails to produce generalizable results, but because
the unvaccinated person poses a potential threat of contagion to others
in the circumstances of an epidemic. Focusing on generalizability
misses the point.
Ever since the Common Rule came into effect, there have been
tortured efforts to draw a sensible line between “public health practice” (which does not require consent) and “public health research”
(which does). Various analytical frameworks have been proposed that
consider multiple factors in addition to whether generalizable
knowledge is being produced.308 The fact remains, however, that generalizability of results gives rise to a presumption that an activity is
“research” that will require informed consent, and there is no clear,
reproducible standard for overcoming that presumption. Public health
actions that produce generalizable knowledge, with minor exceptions,309 require informed consent.
306. See id. §§ 160.102–160.103 (defining the “covered entities” to which the HIPAA
Privacy Rule applies).
307. Jacobson v. Massachusetts, 197 U.S. 11, 38–39 (1905).
308. See, e.g., JAMES G. HODGE, JR. & LAWRENCE O. GOSTIN, COUNCIL OF STATE &
TERRITORIAL EPIDEMIOLOGISTS, PUBLIC HEALTH PRACTICE VS. RESEARCH 7 (2004), available at http://www.cste.org/pdffiles/newpdffiles/CSTEPHResRptHodgeFinal.5.24.04.pdf;
Amoroso & Middaugh, supra note 33, at 250–53; Ctrs. for Disease Control & Prevention,
U.S. Dep’t of Health & Human Servs., HIPAA Privacy Rule and Public Health, MORBIDITY
& MORTALITY WKLY. REP., Apr. 11, 2003, at 1, 10, available at
http://www.cdc.gov/mmwr/pdf/other/m2e411.pdf; James G. Hodge, Jr., An Enhanced Approach to Distinguishing Public Health Practice and Human Subjects Research, 33 J.L.
MED. & ETHICS 125, 127–29 (2005); Dixie E. Snider, Jr. & Donna F. Stroup, Defining
Research When It Comes to Public Health, 112 PUB. HEALTH REPS. 29, 30 (1997); CTRS.
FOR DISEASE CONTROL & PREVENTION, U.S. DEP’T OF HEALTH AND HUMAN SERVS.,
GUIDELINES FOR DEFINING PUBLIC HEALTH RESEARCH AND NON-RESEARCH 2 (1999),
available at http://www.cdc.gov/od/science/integrity/docs/defining-public-health-researchnon-research-1999.pdf; Office for Prot. from Research Risks, OPRR Guidance on 45 C.F.R.
§ 46.101(b)(5): Exemption for Research and Demonstration Projects on Public Benefit and
Service
Programs,
U.S.
DEP’T
OF
HEALTH
AND
HUMAN
SERVS.,
http://www.hhs.gov/ohrp/policy/exmpt-pb.html (last visited Nov. 14, 2008).
309. See CTRS. FOR DISEASE CONTROL & PREVENTION, U.S. DEP’T OF HEALTH AND
HUMAN SERVS., GUIDELINES FOR DEFINING PUBLIC HEALTH RESEARCH AND NONRESEARCH, supra note 308, at 10 (giving the example that it would be acceptable to make
nonconsensual use of the health data of virus outbreak victims on a cruise ship to try to
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The distinction between public health practice and public health
research is extremely problematic as applied to public health uses of
people’s data, as opposed to public health actions that affect their
bodies. Exercises of the state’s police power can be enjoined only
when they are illegitimate, as when the government acts beyond its
constitutional powers or infringes a constitutional right.310 There are
real constitutional limits on the government’s power to touch people’s
bodies.311 Governmental touching of a person’s data raises fewer constitutional problems.312 Unconsented public health research on people’s bodies would implicate constitutional protections against bodily
invasion.313 Unconsented informational research by a public health
agency does not trigger these same concerns.
The distinction between public health practice and research, when
applied to uses of people’s data, has the effect of drastically narrowing the scope of the state’s police power in the area of public health.
The state, when legitimately exercising its police power, can require
its citizens to enter nonconsensual transactions that benefit the public.314 Any legitimate exercise of the police power — including those
that produce generalizable knowledge — can support the imposition
of nonconsensual requirements on citizens. Nowhere, other than under
the Common Rule, does law parse legitimate exercises of the police
power into those that produce generalizable knowledge — and thus
require consent — and those that do not. Indeed, actions that produce
generalizable knowledge offer greater benefit to the public and, if
anything, present a stronger case for nonconsensual access to data.
identify the cause of the outbreak, even though the knowledge gained is generalizable in that
it likely will benefit future cruise passengers).
310. See Merrill, supra note 61, at 70.
311. See Newman v. Sathyavaglswaran, 287 F.3d 786, 789 (9th Cir. 2002) (“[T]he Supreme Court repeatedly has affirmed that ‘the right of every individual to the possession and
control of his own person, free from all restraint or interference of others’ . . . is ‘so rooted
in the traditions and conscience of our people,’ . . . as to be ranked as one of the fundamental liberties protected by the ‘substantive’ component of the Due Process Clause.”) (citing
Schmerber v. California, 384 U.S. 757, 772 (1966) (“The integrity of an individual’s person
is a cherished value of our society.”), Rochin v. California, 342 U.S. 165, 174 (1952) (describing unauthorized physical invasions of the body as “offensive to human dignity”), and
Union Pac. Ry. Co. v. Botsford, 141 U.S. 250, 251 (1891) (discussing “the right of every
individual to the possession and control of his own person, free from all restraint or interference of others”)).
312. See Whalen v. Roe, 429 U.S. 589, 593–94, 600–04 (1977) (upholding a New York
statute that let a state public health agency collect data on patients who had been prescribed
Schedule II controlled substances and finding that patients had a liberty interest in informational privacy but that the interest was not fundamental under the facts of this case); Helen
L. Gilbert, Minors’ Constitutional Right to Informational Privacy, 74 U. CHI. L. REV. 1375,
1381–83 (2007) (noting significant variations in how the various federal circuits handle
information privacy claims after Whalen, with one circuit rejecting altogether the notion that
patients have a fundamental interest in informational privacy).
313. See supra note 311.
314. See Hart, supra note 67, at 1107.
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Treating generalizability as grounds to require consent for informational research, as the Common Rule does, yields the wrong answer:
consent requirements are imposed in inverse proportion to the amount
of public benefit the use will generate.
The recent ANPRM315 appears poised to perpetuate this problem.
In a critical passage, it questions whether the Common Rule should
apply to public health and quality improvement activities, but the last
sentence of this passage suggests that activities that aim to produce
generalizable knowledge should be regulated.316 Successful modernization of the Common Rule requires recognition of the following
point: the state’s police power to protect public health encompasses a
power to use data to create generalizable knowledge. The Common
Rule, as currently applied, misses this point. As a result, legitimate
exercises of the state’s police power are being thwarted.
An example was seen recently, when Congress authorized a large
health data network317 that will use patients’ clinical and insurance
claims data to conduct drug safety surveillance and other studies that
have the potential to produce generalizable knowledge.318 Congress
clearly has power to legislate to protect the public health,319 and it is
almost inconceivable that modern courts would question a congressional determination that the public health benefits of these activities
are sufficient to warrant access to patients’ data.320 It thus seems singularly inappropriate for private IRBs to second-guess Congress’s
decisions. To clarify the role of IRBs in overseeing these activities,
the Director of HHS’s Office for Human Research Protections
(“OHRP”) made a determination that the congressionally authorized
data uses are public health activities that are not subject to the Common Rule.321 Nevertheless, in one recent public health study using this
network, IRBs refused access to roughly five percent of the requested
315. HHS, ANPRM, supra note 5.
316. Id. at 44,521 question 24.
317. See 21 U.S.C.A. § 355(k)(3)(C) (West 2006 & Supp. 2011) (describing the new
“[p]ostmarket [r]isk [i]dentification and [a]nalysis [s]ystem”); see also supra notes 203–205
and accompanying text.
318. See 21 U.S.C.A. § 355(k)(3)(C)(i)(I)–(VI) (West 2006 & Supp. 2011); see Evans,
supra note 25, at 601–02 (discussing the purposes for which Congress authorized development of the Sentinel network).
319. See Parmet, supra note 69, at 202–03 (discussing the scope of the police power to
protect public health).
320. See Merrill, supra note 61, at 63 (discussing eminent domain cases in which courts
accorded “extreme deference” to legislative findings that activity offered public benefit).
321. See, e.g., Letter from Jerry Menikoff, Director, Office for Human Research Prots., to
Rachel E. Behrman, Acting Assoc. Dir. of Med. Policy, Center for Drug Evaluation and
Research, U.S. Food & Drug Admin. (Jan 19, 2010), in HIPAA AND COMMON RULE
COMPLIANCE IN THE MINI-SENTINEL PILOT 10, 10 (2010), available at http://minisentinel.org/work_products/About_Us/HIPAA_and_CommonRuleCompliance_in_the_MiniSentinelPilot.pdf (deeming Sentinel activities not to be regulated by the Common Rule).
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data.322 To date, there has been a surprising lack of debate about
whether it is appropriate for private IRBs to nullify congressional determinations of what is in the American public’s interest.
These problems with the Common Rule could be fixed by conforming it to the HIPAA Privacy Rule’s treatment of public health
activities. The Privacy Rule was specifically designed to regulate disclosures and uses of data, as opposed to interventional activities, and
it directly addresses public health uses of data.323 It expressly allows
data holders to make nonconsensual disclosures of data to a “public
health authority that is authorized by law to collect or receive such
information”324 for various purposes, including public health “investigations”325 — a broad term that could encompass “systematic investigation[s] . . . [that] contribute to generalizable knowledge,” which is
how HIPAA defines research.326 Even if the breadth of that term is
debatable, the Privacy Rule makes several things perfectly clear: the
data holder does not need to conduct an IRB review327 or make any
inquiry into the nature of the intended data use when disclosing data
to public health authorities.328 It merely needs to verify that the person
requesting the data is a public health official329 with legal authority to
request the data330 and that the requested data are the minimum neces322. SARAH L. CUTRONA, ET AL., MINI-SENTINEL SYSTEMATIC VALIDATION OF HEALTH
OUTCOME OF INTEREST: ACUTE MYOCARDIAL INFARCTION CASE REPORT, 10, 12 (2010),
available at http://www.mini-sentinel.org/work_products/Validation_HealthOutcomes/
Mini-Sentinel-Validation-of-AMI-Cases.pdf (noting that even when researchers requested
data for a well-documented public health purpose, IRBs refused to provide 7 of 153 — or
4.6% — of the requested medical records and insisted that patient consent was required).
323. See 45 C.F.R. § 164.512(b) (2010) (outlining standards for disclosure and use of data for public health activities).
324. Id. § 164.512(b)(1)(i); see also id. § 164.501 (defining public health authorities to
include public agencies as well as entities acting under a contract with an agency).
325. Id. § 164.512(b)(1)(i).
326. Id. § 164.501.
327. Id. § 164.512(b)(1); see also KRISTEN ROSATI ET AL., MINI SENTINEL PRIVACY
PANEL, HIPAA AND COMMON RULE COMPLIANCE IN THE MINI-SENTINEL PILOT 7 (2010),
available
at
http://mini-sentinel.org/work_products/About_Us/HIPAA_and_
CommonRuleCompliance_in_the_Mini-SentinelPilot.pdf (stating in a White Paper published by F.D.A.’s Mini-Sentinel pilot project that “the HIPAA Privacy Rule does not require the covered entity [data holder] to have an IRB or Privacy Board determine whether
the covered entity may make the disclosure” when disclosing protected health information
to a public health authority).
328. Id. at 7.
329. 45 C.F.R. § 164.514(h)(2)(ii) (2010) (allowing disclosure to officials including
agency employees and persons who can prove they have a contract or other authorization to
act on the government’s behalf).
330. Id. § 164.514(h)(2)(iii) (allowing the covered entity to rely on the written statement
of a public agency regarding the legal authority under which it is requesting protected health
information, or an oral statement if a written statement is impracticable); see also Standards
for Privacy of Individually Identifiable Health Information, 65 Fed. Reg. 82,462, 82,547
(Dec. 28, 2000) (explaining in the Preamble to the Privacy Rule that the verification process
can rely on “reasonable” documentation).
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sary to fulfill the public health purpose.331 The data holder is entitled
to rely on the public health authority’s representations that the data
request is legally authorized and meets the minimum necessary condition.332
These provisions differ starkly from the Common Rule’s treatment of public health uses of data, but this fact is poorly understood.
The IOM’s 2009 study of the HIPAA Privacy Rule discussed the distinction between public health practice and public health research at
some length333 and seemed to suggest that IRBs need to parse this
distinction when administering the HIPAA Privacy Rule.334 The regulation does not require this; the HIPAA Privacy Rule envisions no
IRB involvement in disclosures of data to public health authorities.335
Misunderstandings about this fact continue to hinder public health
access to data. The HIPAA Privacy Rule appropriately defers to legislatures to decide the appropriate scope of the police power to use data
to protect the public’s health. It is not for executive agencies, or for
the private institutional review bodies they empower, to second-guess
these determinations. The Common Rule makes the state’s police
power subject to nullification by private and potentially conflicted
IRBs336 — a matter that is all the more troubling in light of the lax
procedural norms under which these bodies operate.337
B. Developing a Workable Doctrine of Public Use of Private Data
The second neglected question is how to determine which uses of
data warrant nonconsensual access to private data. Existing pathways
331. 45 C.F.R. § 164.514(d)(3)(iii) (2010). While § 13405(b) of the HITECH Act, codified at 42 U.S.C.A. § 17935 (West 2010 & Supp. 2011), contains a provision that requires
covered entities to determine what is the minimum amount of protected health information
for a disclosure, recently proposed amendments to the HIPAA Privacy Rule to implement
the HITECH Act did not modify a covered entity’s ability to rely on minimum necessary
representations by public officials. See Modifications to the HIPAA Privacy, Security, and
Enforcement Rules Under the Health Information Technology for Economic and Clinical
Health Act, 75 Fed. Reg. 40,868, 40,922–23 (July 14, 2010) (to be codified at 45 C.F.R. pts.
160, 164) (proposing a revised regulation to be codified at 45 C.F.R. § 164.514, which has
not been finalized as of this writing).
332. See supra notes 330–31 and accompanying text.
333. IOM, PRIVACY REPORT, supra note 3, at 133–36.
334. See id. at 131, 133 (asserting that the Privacy Rule makes the same distinction between public health practice and research that the Common Rule makes and suggesting that
it is important for IRBs to be able to distinguish public health practice and public health
research when implementing the Privacy Rule).
335. See supra note 332 and accompanying text.
336. See Evans, supra note 96, at 332 (discussing potential IRB conflicts of interest); Evans, supra note 89, at 5 (same).
337. See Evans, supra note 96, at 332 (discussing the lax procedural requirements
HIPAA imposes); Coleman, supra note 102, at 13–17 (discussing procedural informality of
the Common Rule); Evans, supra note 25, at 622–25 (discussing procedural problems with
the Common Rule’s waiver provisions).
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for nonconsensual use of data under the Common Rule and HIPAA
Privacy Rule338 were developed in an ad hoc manner to preserve specific uses of data that already had well-established histories before
these regulations came into force. For example, health data had been
widely used in research without consent in the decades before the
Common Rule came into existence.339 The regulations preserved
preexisting uses without enunciating a coherent theory explaining
why — and which — data uses justify nonconsensual access. The
waiver provisions of the HIPAA Privacy Rule and the Common Rule
lack a “public use” requirement — a criterion, similar to the one used
in eminent domain jurisprudence340 — that requires nonconsensual
research uses to serve a publicly beneficial purpose.341
1. How the Public Use Requirement Got Lost
There is wide agreement among bioethicists that the “central ethical issue” in health informational research is to ensure that the potential public benefits are sufficient to warrant the burden on the
individual.342 At every stage of the process that led to development of
the Common Rule and the HIPAA Privacy Rule, advisory bodies that
pondered nonconsensual research use of data called for a utilitarian
balancing of public and private interests. It is worth tracing this history because it came to an anomalous result: the waiver provisions of
both regulations, as finally promulgated, lack criteria that require such
a balancing.
338. See Evans, supra note 89, at 4 (summarizing pathways for nonconsensual use of data under the Common Rule and HIPAA Privacy Rule).
339. See HEW, 1978 REPORT, supra note 8, at 56,188 (noting that a survey of investigators, conducted as part of efforts to develop the Common Rule, found that the fact that a
“study was based exclusively upon existing records” was commonly cited as a reason why
consent was unnecessary).
340. See supra notes 70–77 and accompanying text.
341. Merrill, supra note 61, at 61.
342. Casarett et al., supra note 9, at 597 (“The central ethical issue in pharmacoepidemiologic research is deciding what kinds of projects will generate generalizable knowledge that
is widely available and highly valued, and do this in a manner that protects individuals’
right to privacy and confidentiality.”); see also NATIONAL BIOETHICS ADVISORY
COMMISSION, 1 ETHICAL AND POLICY ISSUES IN RESEARCH INVOLVING HUMAN
PARTICIPANTS
xviii,
103–04
(Aug.
2001),
available
at
http://bioethics.georgetown.edu/nbac/human/overvol1.pdf (recognizing the need for nonconsensual data use in some circumstances and including, as a necessary criterion, that an
IRB determine that “the benefits from the knowledge to be gained from the research study
outweigh any dignitary harm associated with not seeking informed consent”); Peter D.
Jacobson, Medical Records and HIPAA: Is It Too Late to Protect Privacy?, 86 MINN. L.
REV. 1497, 1497–99 (2002) (arguing that the most important issue to resolve is which public health objectives are sufficiently important to override the individual’s interest in nondisclosure).
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The earliest precursor of the Common Rule was a set of 1974
regulations that required informed consent and IRB review of research, with no provision for consent to be waived.343 The National
Commission’s recommendations about human-subject protections,
published in 1978, focused primarily on interventional and behavioral
research.344 The Commission discussed waiving or altering consent,
but not with respect to the use of data.345 The report separately addressed research that relies on existing documents, records, or tissue
specimens and stated several principles: “If the subjects are not identified or identifiable, the research need not be considered to involve
human subjects,” and consent requirements should not apply.346 Even
“where the subjects are identified, informed consent may be deemed
unnecessary” provided certain conditions are met.347 These conditions
included a public use requirement: an IRB must determine that “the
importance of the research justifies such invasion of the subjects’ privacy.”348
The Department of Health, Education, and Welfare (“HEW”),
precursor of today’s HHS, commenced proceedings in 1979 to incorporate the National Commission’s recommendations into its existing
regulations.349 The proposed regulation did not include a waiver provision. HEW explained that it was instead considering whether certain
types of behavioral research and research with data should be exempt
from the regulations altogether and thus not subject to a consent requirement at all.350 HEW sought comments on how to handle research
with data. What is striking is that the unconsented use of data was, at
that time, a matter of considerable indifference. Fewer than twenty
commenters discussed the proposed exemption for studies with exist-
343. Protection of Human Subjects, 39 Fed. Reg. 18,914 (May 30, 1974) (codified at 45
C.F.R. pt. 46).
344. See HEW, 1978 REPORT, supra note 8.
345. Id. at 56,180–81 (discussing consent waivers for certain types of behavioral research).
346. Id. at 56,181.
347. Id.
348. Id. at 56,179; see also id. at 56,181 (reporting findings of a Privacy Protection Study
Commission, under the auspices of the National Commission, which elaborated this balancing requirement more specifically: “[M]edical records can legitimately be used for biomedical or epidemiological research, without the individual’s explicit authorization,” provided
that the medical care provider (who in all likelihood would have been the data holder in that
era of paper records) determines “that the importance of the research or statistical purpose
for which any use of disclosure is to be made is such as to warrant the risk to the individual
from additional exposure of the record or information contained therein,” and provided that
an IRB ensures this condition has been met).
349. Proposed Regulations Amending Basic HEW Policy for Protection of Human Research Subjects, 44 Fed. Reg. 47,688 (Aug. 14, 1979) (to be codified at 45 C.F.R. pt. 46).
350. Id. at 47,692.
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ing data,351 whereas other issues in the proceeding drew over 500
comments.352 Most of those who commented favored exempting research uses of data from consent requirements altogether.353 The final
rule exempted research in which the investigator records data in a deidentified manner.354 This exemption still exists in the modern Common Rule.355
What HEW did not address was whether consent could be waived
for research that requires access to identified or identifiable data. This
type of research later gained importance as post-1980 advances in
information technology made it possible to link patients’ records from
multiple sources to form LHRs356 — a process that requires at least
some access to identifying information.357 The National Commission,
in its 1978 report, had called for a mechanism to allow unconsented
research access to identified data and records.358 HEW and its successor, HHS, did not address this recommendation in their 1979 to 1981
rulemaking process.
The final regulation promulgated in 1981 did, however, insert a
waiver provision359 identical to the one that still exists in the Common
Rule.360 In explaining why it had inserted this provision so late in the
regulatory proceedings, HHS made no reference to nonconsensual
data use. Rather, the waiver provision was a response to an altogether
different problem: research into the optimal design of federal benefit
programs.361 This explains why the Common Rule’s waiver provision
contains no public use requirement for nonconsensual data access.
351. Final Regulations Amending Basic HHS Policy for the Protection of Human Research Subjects, 46 Fed. Reg. 8366, 8372 (Jan. 26, 1981).
352. Id. at 8368.
353. Id. at 8372.
354. Id. at 8387.
355. 45 C.F.R. § 46.101(b)(4) (2010). But see HHS, ANPRM, supra note 5, at 44,518–
44, 44,521, 44,527 tbl.1 (proposing to require consent for certain exempt data uses that do
not presently require consent).
356. See discussion supra Part III.B.
357. Id.
358. HEW, 1978 REPORT, supra note 8, at 56,179–80.
359. Final Regulations Amending Basic HHS Policy for the Protection of Human Research Subjects, 46 Fed. Reg. 8366, 8390 (Jan. 26, 1981).
360. 45 C.F.R. § 46.116(d) (2010).
361. Final Regulations Amending Basic HHS Policy for the Protection of Human Research Subjects, 46 Fed. Reg. at 8383. HHS was responding to Crane v. Mathews, 417 F.
Supp. 532 (N.D. Ga. 1976), which had held that IRB review should have applied to certain
randomized studies that varied Medicaid benefits to observe impacts on beneficiaries’ consumption of healthcare. HEW had responded hastily with a strained interpretation of the
Common Rule that attempted to place such studies outside the scope of its regulations. See
Secretary’s Interpretation of “Subject at Risk”, 41 Fed. Reg. 26,572 (Jun. 28, 1976). The
issue continued to simmer and, as HHS promulgated the final revised regulations in 1981, it
tried a different solution: HHS admitted that such research should be subject to IRB review
but added a provision to allow waiver of informed consent. Final Regulations Amending
Basic HHS Policy for the Protection of Human Research Subjects, 46 Fed. Reg. at 8383.
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The waiver provision, when initially implemented, was not intended
for use in approving nonconsensual data uses, so it did not incorporate
the balancing test the National Commission had recommended.362
When the waiver provision was later pressed into service for approving nonconsensual data uses, the waiver criteria were not updated for
this new purpose.
The more recent HIPAA waiver provision presents a different story. The HIPAA Privacy Rule, though it has been criticized, was the
product of a thoughtful and well-researched rulemaking process.363
When developing its proposed regulation, HHS understood that waiving consent for informational research raises issues that would not be
adequately addressed by simply copying the waiver criteria of the
Common Rule.364 Instead, HHS started from scratch and proposed a
new set of waiver criteria. These included a requirement that an IRB
make a determination that “the research is of sufficient importance so
as to outweigh the intrusion of the privacy of the individual whose
information is subject to the disclosure.”365 Unfortunately, this criterion drew “a large number” of adverse comments.366 Some commenters
warned that the criterion was subjective and would be inconsistently
applied by IRBs; others criticized its reliance on conflicting value
judgments as to whether research is important.367
In response to these comments, the December 2000 version of the
HIPAA Privacy Rule368 revised the balancing criterion, conforming it
to a familiar test that IRBs routinely perform when approving any
research, whether consented or unconsented: the risks of research
must be reasonable in relation to the anticipated benefits of the research — if any — to the individual and the importance of the
knowledge that may reasonably be expected to result from the research.369 This change was wrongheaded. This criterion, which appears at section 46.111(a)(2) of the Common Rule, is a minimum
threshold for acceptability of research.370 Research that does not meet
this criterion is considered so devoid of scientific merit that an IRB
362. See HEW, 1978 REPORT, supra note 8, at 56,181.
363. See Standards for Privacy of Individually Identifiable Health Information, 65 Fed.
Reg. 82,462, 82,463–66 (Dec. 28, 2000) (discussing the rationale for HIPAA’s various
provisions in the preamble to the initial HIPAA Privacy Rule).
364. See id. at 82,697 (noting that the Common Rule’s waiver criteria were not explicitly
directed at protecting the privacy interests that the HIPAA privacy rule protects).
365. Id. at 82,698.
366. Id.
367. Id.
368. Id.
369. 45 C.F.R. § 46.111(a)(2) (2010).
370. Id.
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cannot ethically allow people to consent to it.371 Adopting this criterion of minimal acceptability as the criterion for approving a waiver
was nonsensical: in any situation where consent could be allowed, it
could be waived. This was not the sort of public use requirement the
National Commission had proposed.
HHS had an opportunity to correct this error two years later,
when a new administration asked HHS to revisit the HIPAA Privacy
Rule.372 Unfortunately, the correction took the form of jettisoning the
troublesome balancing requirement altogether.373 The currently effective HIPAA waiver provision, like its counterpart in the Common
Rule, has no requirement that the proposed research offer any public
benefit.374 These waiver provisions are functionally equivalent to a
private delegation of takings power375 without any public use requirement whatsoever.
2. Clarifying the Concept of Public Use of Data in Research
Those who expressed concern during the first HIPAA rulemaking
about IRBs’ ability to balance public and private interests376 may have
had a point. Utilitarian balancing is fundamentally at odds with the
autonomy-based bioethical principles these regulations seek to uphold. The interests in the balance are incommensurable.377 Miller has
pointed out that even if research has high social value, if consent is
logistically difficult or impossible to obtain, and if a consent requirement may undercut the scientific validity of results, these facts “do
not in themselves constitute valid ethical reasons for waiving a requirement of informed consent.”378
The field of bioethics has drawn heavily on an atomistic concept
of autonomy that portrays individuals as “self-reliant, self-governing,
371. See HEW, 1978 REPORT, supra note 8, at 56,180 (advancing the principle that subjects should not be exposed to research that falls below a minimal threshold of scientific
quality).
372. See Standards for Privacy of Individually Identifiable Health Information, 67 Fed.
Reg. 53,182 (Aug. 14, 2002).
373. See id. at 53,270.
374. See 45 C.F.R. § 46.116(d) (2010) (Common Rule); id. § 164.512(i) (2010) (HIPAA
Privacy Rule).
375. See discussion supra Part II.B.
376. See discussion supra Part V.B.1.
377. For examples of the analogous critique of balancing in other contexts, see T. Alexander Aleinikoff, Constitutional Law in the Age of Balancing, 96 YALE L.J. 943 (1987)
(critiquing the balancing of public and private interests in twentieth-century constitutional
interpretation); Richard H. Pildes, Avoiding Balancing: The Role of Exclusionary Reasons
in Constitutional Law, 45 HASTINGS L.J. 711 (1994) (same); Jed Rubenfeld, The First
Amendment’s Purpose, 53 STAN. L. REV. 767, 778–797 (2001) (critiquing balancing as a
method of First Amendment interpretation).
378. Franklin G. Miller, Research on Medical Records Without Informed Consent, 36
J.L. MED. & ETHICS 560, 560 (2008) (discussing but not necessarily endorsing this view).
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and fundamentally alone.”379 Tauber has remarked that foundational
works of modern bioethics from the years 1954 to 1970 fail to delineate how the principle of autonomy competes with other moral tenets.380 After 1980, bioethicists began to explore alternative views of
autonomy as “not merely an internal, or psychological characteristic
but also an external, or social characteristic,”381 with individuals
achieving autonomy in cooperation rather than in isolation.382 Alternatives to a consent-based model have been proposed,383 but they lack
specifics about how to make decisions to allow nonconsensual use of
data in service of broader public interests. Modern takings jurisprudence has been equally unable to resolve such trade-offs.384
Nonconsensual research use of data is a “muddle”385 strikingly
similar to the one that has afflicted regulatory takings jurisprudence386
in the years after Penn Central Transportation Co. v. New York
City.387 In that case, the Supreme Court applied utilitarian balancing
of public and private interests to deny compensation to Penn Central
when the city’s Landmark Commission restricted its ability to develop
the airspace above Grand Central Station, even though the restriction
inflicted a major financial loss on Penn Central for the public’s benefit.388 The Court applied a deferential “rational basis” review that presumed “regulation has high social value whenever it is ‘reasonably
related to the promotion of the general welfare.’”389 The HIPAA and
Common Rule waiver criteria abandon even the attempt to perform
utilitarian balancing. This amounts to a presumption that informational research has high social value. This arguably may be the right decision: research generates positive externalities, and it is hard to assess
379. ALFRED I. TAUBER, PATIENT AUTONOMY AND THE ETHICS OF RESPONSIBILITY 13
(2005).
380. Id. at 16.
381. Id. at 120 (quoting GRACE CLEMENT, CARE, AUTONOMY, AND JUSTICE: FEMINISM
AND THE ETHIC OF CARE 22 (1996)); see also id. at 85 (“[I]f the self is understood as a
confluence of relationships and social obligations that are constitutive of identity, then autonomy may legitimately be subordinated to other moral principles that determine how the
self is governed within a social context.”).
382. Id. at 122.
383. IOM, PRIVACY REPORT, supra note 3, at 254–55 (reviewing and discussing several
models).
384. See Merrill, supra note 61, at 63–64 (lamenting the lack of clear standards for determining public use).
385. See Carol M. Rose, Mahon Reconstructed: Why the Takings Issue Is Still a Muddle,
57 S. CAL. L. REV. 561 (1984); Louise A. Halper, Why the Nuisance Knot Can’t Undo the
Takings Muddle, 28 IND. L. REV. 329 (1995).
386. See Claeys, supra note 58, at 1555 (“[M]odern regulatory takings law is widely recognized to be a ‘muddle.’”).
387. 438 U.S. 104 (1978).
388. See id. at 124, 130–34.
389. Claeys, supra note 58, at 1557 (quoting Penn Central, 438 U.S. at 131); see also
Merrill, supra note 61, at 63–65 (discussing judicial deference to legislative findings of
public benefit).
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a priori which lines of research will ultimately pay off. It may be that
it benefits society to encourage all research; however, this is a decision that a society needs to make through deliberation.390 After reviewing the development of today’s waiver criteria, it is obvious this
deliberation never took place.
3. Developing a Workable Public Use Criterion
For waivers to merit public trust, a workable public use criterion
needs to be enunciated. The takings muddle suggests by analogy that
there will be no easy solution. However, it also offers a number of
possible approaches that may be worth exploring.
A. Focus Not on How Decisions Should Be Made, but by Whom
Deciding which lines of research offer substantial social benefits
requires a global perspective that local IRBs do not possess. A centralized, national oversight body or a legislature is better positioned to
assess which lines of research warrant nonconsensual data access.
One possible approach would be to form a publicly accountable body
to identify general categories of research that offer public benefit. Patient advocacy groups could petition it to allow data access for research into their “pet” diseases, much as they lobby Congress for
research funding for specific diseases today.391 When Congress has
authorized specific lines of health informational research, as it did in
FDAAA392 and in the comparative effectiveness provisions of the Patient Protection and Affordable Care Act of 2010,393 this should be
treated as a Blackstonian “consent of the people” to the research. Private IRBs should not be tasked with second-guessing determinations
of public benefit that a duly elected legislature has already made. In
an exercise of their enforcement discretion, OHRP and OCR could
issue guidance creating a safe harbor that deems data holders to have
390. See DANIEL CALLAHAN, WHAT PRICE BETTER HEALTH? (2006) (listing issues a society should resolve through deliberation and challenging the notion that medical research is
inherently good and should be pursued without regard to the burdens it places on competing
values).
391. See REBECCA DRESSER, WHEN SCIENCE OFFERS SALVATION (2001) (discussing the
role of patient advocacy groups in influencing national research policy and allocation of
resources to research).
392. 21 U.S.C.A. § 355(k)(3)(C)(i)(I)-(VI) (West 2006 & Supp. 2011); see also Evans,
supra note 25, at 601–02 (discussing the purposes for which Congress authorized development of the Sentinel system).
393. Pub L. No. 111-148, 124 Stat. 119 (codified as amended in scattered sections of 42
U.S.C. and I.R.C.); see, e.g., id. § 6301; 42 U.S.C. §§ 1301–1320d-8 (2006) (amending Title
XI of the Social Security Act by adding Part D — Comparative Clinical Effectiveness Research).
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complied with the regulations when they make data available for legislatively authorized research uses.
B. Develop Rules of Thumb for Identifying Suspect, “Non-Public”
Uses of Data
Merrill has suggested an analytical approach that focuses on identifying the traits that cause some takings to lack sufficient public purpose.394 These presumptively private uses then can be singled out for
more skeptical regulatory oversight.395 In the same way, it may be
easier to state what a publicly beneficial use of data is not than to
specify what it is. The idea is to develop a list of red flags that weaken
the presumption that a proposed research use of data offers public
benefit. To take one example, there is not presently a health informational research registry that serves the same purpose as ClinicalTrials.gov, where sponsors of clinical trials disclose information about
their planned projects.396 It sometimes is alleged that academic and
commercial researchers would be reluctant to disclose their planned
informational research activities, since doing so would give away
their corporate strategies and research ideas. Unwillingness to disclose
research plans might be viewed as a red flag signaling that a data use
has primarily a private purpose. Private-purpose data uses still would
be allowed, but they would require informed consent. Persons wishing
to use the public’s health information must be prepared to disclose
what they intend to do with it.
C. Reject Utilitarian Balancing in Favor of Natural Rights Analysis
Nineteenth-century state courts analyzed takings cases under natural rights principles that grounded property rights in personhood397 — an approach that bears considerable resemblance to modern bioethical analysis that grounds privacy rights in autonomy.
Claeys has argued rather persuasively that the old natural rights analysis did a better job of drawing sensible lines than modern utilitarian
balancing can do.398 Of particular interest are cases where state ac394. See Merrill, supra note 61, at 90–92 (identifying a need for heightened scrutiny of
takings in which there is high subjective valuation of the taken property, there is a potential
for secondary rent seeking, and where there has been an intentional or negligent bypass of a
thick market).
395. See id.
396. See CLINICALTRIALS.GOV, http://www.clinicaltrials.gov (last visited Dec. 21, 2011).
397. Claeys, supra note 58, at 1577–86 (discussing nineteenth-century state courts’ natural rights analysis of eminent domain cases involving state actions to abate private nuisances
or to protect public health, safety, morals, and order).
398. See id. (examining nineteenth-century takings cases that bear similarity to regulatory
takings cases and comparing them to twentieth-century regulatory takings cases); id. at 1556
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tions force individuals to contribute positive externalities to the community: for example, by requiring homeowners to install curbs at their
own expense.399 Such cases require courts to decide whether the action is a noncompensable exercise of police power or a compensated
taking.400 This line-drawing bears conceptual similarities to the problem of distinguishing public health uses from research uses of data. In
the latter problem, monetary compensation is not at stake;401 what is
at stake is whether the activity will be subject to the Common Rule’s
oversight requirements.
Natural rights analysis held that owners are not entitled to takings
compensation
when
they
receive
“implicit
in-kind”
tion402 — for example, when each homeowner who is forced to make
improvements enjoys “reciprocity of advantage”403 and will benefit
from the improvements others are forced to install.404 This was cast as
the state using its police powers to force a mutually advantageous exchange that would be hard for individuals to organize by themselves;
each affected person gives something to, and gets something from, the
others. When there was no reciprocity of advantage — that is, when
the burdens of a measure to benefit the public were disproportionately
visited on some community members — the action was a taking, and
compensation was owed.405
The notion of reciprocity of advantage survives in modern bioethical criteria for assessing whether a particular data use is “public
health practice” that can be conducted without informed consent.406 If
(“Takings law gets muddled only when it applies a certain kind of utilitarian property theory
to regulatory takings.”).
399. See Palmyra v. Morton, 25 Mo. 593, 593 (1857) (upholding a town ordinance requiring homeowners to curb and pave footpaths in front of their homes at their own expense).
400. See Merrill, supra note 61, at 65 (describing a continuum of consensual transactions,
compensated takings, and uncompensated confiscation or interference with property rights
under the police power).
401. See supra notes 79–84 and accompanying text (explaining why nonconsensual research uses of data would not be compensable even if data were patient-owned).
402. Claeys, supra note 58, at 1589 (citing RICHARD A. EPSTEIN, TAKINGS: PRIVATE
PROPERTY AND THE POWER OF EMINENT DOMAIN 195–215 (1985) and Frank I. Michelman,
supra note 82, at 1225–26).
403. Id. at 1587–89, 1619–21 (tracing the “reciprocity of advantage” or “common benefit
of all” concepts in nineteenth and early twentieth-century state and federal cases and noting
the twentieth-century trend to supplant natural-law analysis with utilitarian principles); id. at
1633 (noting occasional references to reciprocity of advantage in modern Supreme Court
cases but observing that modern applications have “diluted the principle so much that it is
now meaningless”).
404. Id. at 1557, 1589 (citing Paxson v. Sweet, 13 N.J.L. 196, 199 (1832)).
405. Id. at 1570 (discussing the early case, Vanhorne’s Lessee v. Dorrance, 2 U.S. (2
Dall.) 304 (C.C.D. Pa. 1795), which enunciated the notion that there is a taking when governmental action lays “a burden upon an individual, which ought to be sustained by society
at large” (Id. at 310)).
406. See HODGE & GOSTIN, supra note 308, at 7, 9, 52.
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benefits of a study will flow primarily to the people whose data are
used, as opposed to being generalizable to other populations, this
weighs in favor of a finding that the study is public health practice.407
The criterion of “benefits internal to the community” is simply reciprocity of advantage under a different name. Unfortunately, modern
IRBs use this criterion in combination with other criteria — such as
generalizability of results — that often muddy the waters.408 The nineteenth-century cases treated reciprocity as central to the analysis.
A similar focus could help identify which nonconsensual uses of
data are acceptable and warrant public trust even in an environment of
strong respect for individual autonomy. Nonconsensual research uses
of data held in large regionally or nationally scaled data networks can
be conceptualized as mutually advantageous exchanges. In this light,
research in very large data networks actually has stronger ethical justification than does research with smaller datasets that force “some
people alone to bear public burdens which, in all fairness and justice,
should be borne by the public as a whole.”409
These and other possible solutions need to be explored. The aim
here is not to advance a particular solution but rather to focus attention on the critical and long-neglected question: what is an appropriate
public use of private data, and how should that decision be made?
VI. CONCLUSION
The primary aim of this Article is to critique recent data
propertization proposals. While ultimately flawed, these proposals
offer a kernel of conceptual value. The property analogy supplies a
helpful lens for viewing a central problem in the debate about the
Common Rule and HIPAA Privacy Rule — specifically, how to address the conflict between patients’ desire to control their data and the
public’s need to use those data for various worthy purposes. This lens
brings into focus two problems that have been neglected in the debate
over access and privacy: that existing regulations, as applied, drastically narrow the state’s police power to harness data for public benefit, and that they fail to subject nonconsensual use of data in
informational research to any public use requirement. Reforms to the
HIPAA Privacy Rule and the Common Rule are unlikely to resolve
the debate if these problems remain unaddressed.
It is not a foregone conclusion, however, that regulatory amendments will be required to address the problems identified in this Article. The Secretary of HHS has discretion, under the existing Common
407. Id. at 9, 52.
408. Id. at 15, 47–52.
409. Armstrong v. United States, 364 U.S. 40, 49 (1960) (Harlan, J., dissenting).
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Rule,410 to determine whether its provisions apply to particular activities. Through an exercise of this authority, the Common Rule’s treatment of public health uses could be brought in line with the HIPAA
Privacy Rule. Guidance from the OCR could help IRBs understand
their role under the latter regulation, which treats public health disclosures appropriately but is widely misunderstood. The use of guidance — by OHRP for the Common Rule, and by the OCR for the
HIPAA Privacy Rule — offers a promising way to clarify criteria for
granting waivers to allow nonconsensual use of data in informational
research. For example, a suitably skilled and representative advisory
body could grapple with the task of characterizing classes of informational research that presumptively amount to a legitimate public use.
The OCR and OHRP then could exercise their enforcement discretion
to issue guidance creating a safe harbor that deems IRBs to have
complied with the waiver criteria when approving such uses but exposes IRBs to further scrutiny when they do not. The point of this
discussion is that the problems identified in this Article are not necessarily difficult to address; they simply have been overlooked. This
neglect counts as a seminal failure in federal efforts to appropriately
regulate health privacy and data access over the past forty years. The
long and intractable debate surrounding privacy, public health uses of
data, and informational research is the open sore that came of this neglect. The neglect needs to end now.
410. 45 C.F.R. § 46.101(c) (2010).